APPROVED
AS MODIFIED
May 09, 2013
WIRB
UCB Pharma SA
RA 0055
20120644
W120412003
TITLE:
RESEARCH SUBJECT INFORMATION AND CONSENT FORM
A
MULTI-CENTER,
RANDOMIZED,
DOUBLE-BLIND,
PLACEBO-CONTROLLED STUDY TO EVALUATE THE
EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN
COMBINATION WITH METHOTREXATE FOR INDUCING AND
SUSTAINING CLINICAL RESPONSE IN THE TREATMENT OF
DMARD-NAÏVE ADULTS WITH EARLY ACTIVE RHEUMATOID
ARTHRITIS
This consent form contains important information to help you decide whether to
participate in a research study.
The study staff will explain this study to you. Ask questions about anything that is not clear at
any time. You may take home an unsigned copy of this consent form to think about and discuss
with family or friends.
1.
2.
3.
4.
Being in a study is voluntary – your choice.
If you join this study, you can still stop at any time.
No one can promise that a study will help you.
Do not join this study unless all of your questions are answered.
After reading and discussing the information in this consent form you should know:






Why this research study is being done;
What will happen during the study;
Any possible benefits to you;
The possible risks to you;
Other options you could choose instead of being in this study;
How your personal health information will be treated during the study and after the study is
over;
 Whether being in this study could involve any cost to you; and
 What to do if you have problems or questions about this study.
Please read this consent form carefully.
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RESEARCH SUBJECT INFORMATION AND CONSENT FORM
TITLE:
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND,
PLACEBO-CONTROLLED STUDY TO EVALUATE THE
EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN
COMBINATION WITH METHOTREXATE FOR INDUCING
AND SUSTAINING CLINICAL RESPONSE IN THE
TREATMENT OF DMARD-NAÏVE ADULTS WITH EARLY
ACTIVE RHEUMATOID ARTHRITIS
PROTOCOL NO.:
RA0055
WIRB® Protocol #20120644
W120412003
SPONSOR:
UCB Pharma SA
INVESTIGATOR:
Jeffrey R. Curtis, M.D., MPH
SRC 076
1717 6th Avenue South
Birmingham, Alabama 35294
United States
SITE(S):
University of Alabama at Birmingham
SRC 076
1717 6th Ave. South
Birmingham, Alabama 35294
United States
STUDY-RELATED
PHONE NUMBER(S):
Created: 03-27-13
Jeffrey R. Curtis, M.D., MPH
205-934-7727
205-934-3411 (24 hour pager)
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INFORMED CONSENT
Before agreeing to participate in this research study, it is important that you read and understand
the following explanation of the proposed research study. This consent document describes the
purpose, procedures, potential benefits, risks, discomforts and precautions of the study. It also
describes the alternative procedures that are available to you and your right to withdraw from the
study at any time. No guarantees or assurances can be made as to the results of the study. Please
ask the study doctor or the study staff to explain any words or information that you do not clearly
understand.
If you are not completely truthful with your study doctor regarding your health history, you may
harm yourself by participating in this study.
You have been asked to participate in a research study initiated, managed, and financed by UCB
Pharma S.A., the Sponsor of this study, which will be referred to in this document as “UCB”.
Your study doctor is being paid by UCB Pharma S.A., to conduct this study.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required
by U.S. Law. This Web site will not include information that can identify you. At most, the
Web site will include a summary of the results. You can search this Web site at any time.
PURPOSE OF THE STUDY
Before you decide to participate in this study, it is important for you to understand why the
study is being done and what it will involve. This information sheet will provide you with
essential information about this study and your rights as a study subject so that you can
make an informed decision about your participation.
If you are not completely truthful with your study doctor regarding your health history, you may
harm yourself by participating in this study.
Your decision to participate in this study is entirely voluntary. You will not lose any benefits to
which you would otherwise be entitled if you refuse to participate. In addition, you may
withdraw from the study at any time without penalty or loss of benefits to which you are
otherwise entitled. You will be informed in a timely manner, if any new information about this
drug or the study itself becomes available that may alter your willingness to continue to
participate. If you agree for him/her to be informed, your General Practitioner/Family physician
will be told that you are taking part in this study. A description of this clinical trial will be
available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not
include information that can identify you. At most, the Web site will include a summary of the
results. You can search this Web site at any time.
Created: 03-27-13
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You will be asked to participate and sign a separate informed consent for an optional
Pharmacogenomics sub-study. Your decision to participate in this sub-study is entirely
voluntary. You may refuse this additional research and still participate in this main RA0055
study.
You are being asked to participate in this clinical research study because you are suffering from
Rheumatoid Arthritis.
The purposes and experimental aspects of this study are to investigate if starting a standard
treatment with a disease-modifying anti-rheumatic drug (also known as DMARD) combined
with certolizumab pegol (the active study drug) in an early stage of your illness can get you into
a condition called ‘remission’ after one year of study, meaning having no or only few disease
symptoms (i.e. swollen or tender joints or almost no pain). The second year of this study is
intended to adapt the treatment and to investigate if a monthly treatment dosing frequency will
still keep you in a ‘minimal sign and symptoms state’ compared to a biweekly (once every 2
weeks) treatment dosing. If your symptoms worsen during the study it will also be investigated if
re-treatment with a bi-weekly dosing frequency can bring you back into the low disease activity
state.
What is the drug being tested in this study?
Certolizumab pegol is a drug approved by the United States (US) Food and Drug Administration
(FDA) for the treatment of moderate to severe active rheumatoid arthritis (RA). This research
study is to determine whether certolizumab pegol can reduce the symptoms of early, progressive
RA.
Certolizumab pegol is an “anti – TNF, humanized Fab′ fragment". Certolizumab pegol works by
blocking an inflammatory substance in the body that is called tumor necrosis factor (TNF).
“Humanized Fab′” means that it has been engineered to act like a piece of a specific antibody
from a human cell. This helps it bind to its target.
This study will involve a total of 800 subjects across approximately 200 centers throughout
Europe, Australia and North- and South-America.
A table of tests, procedures and the visit schedule required for subjects who participate in this
study can be found at the end of this section (see Visit Schedule below).
Study duration:
This study can last up to 116 weeks (2 years and 3 months) but may be shorter in case you do not
improve sufficiently or not at all. In that case your doctor may look for other treatments outside
the study to help you.
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PROCEDURES
Screening Visit:
During your first visit you will receive all needed details on the study and you are free to ask any
type of questions to allow you to evaluate your interest in this study. If you agree to participate in
the study, your study doctor will evaluate your disease as well as review the study entry criteria
to ensure you fulfill all requirements to enter the study. You will be asked to fill out
questionnaires and undergo a number of tests (as described on the Visit Schedule), including a
pregnancy test; ECG (electrical tracing of heart activity); x-rays of chest, hands, wrists, and feet;
tests for tuberculosis (TB) and hepatitis (state law requires that the results of positive tests for
hepatitis and TB be reported to a local health agency); and laboratory tests on blood samples.
This screening period can last 2-4 weeks.
First study year: Week 0 to Week 52:
During the first year there will be two groups;

One active study medication group (receiving certolizumab pegol in addition
to methotrexate) and

One control group receiving placebo in addition to methotrexate (MTX).
Placebo is an inactive substance that looks identical to the active medication.
You will receive either certolizumab pegol or placebo in pre-filled syringes. The study drug
(certolizumab or placebo) must be taken by subcutaneous (sc) injection (meaning just under the
skin) as follows:
 400mg at Weeks 0, 2 and 4, followed by
 200mg every two weeks until Week 50.
The subcutaneous injections can be given in the lateral abdominal wall (the side of your
abdomen), the upper outer part of your thigh or the upper arm.
You will also receive MTX in tablet form and will have to take it on a weekly basis on the same
day of the week from Week 0 onward every week until Week 51. The MTX doses will not
change within the different treatment groups.
The weekly dosage of MTX will be selected and maintained according to your study doctor’s
clinical judgment, but should not be less than 10mg nor higher than 25mg per week at any period
of the study. The recommended starting dose is 10mg per week, the maximum tolerated MTX
dosage will be achieved by Week 8. You may fall back to the lower dosage in case of tolerability
problems; however you must be able to tolerate at least 10mg MTX weekly to remain in the
study.
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You will be randomly assigned to one of the groups with a chance of 75% to be in certolizumab
pegol with methotrexate group and 25% in placebo with methotrexate group.
Your assignment to one of the two groups will be done randomly (by chance) through a phone
call to a central computer system. As you will be participating in a double-blind study, your
study doctor, any of the study staff (with exception of the nurse providing you the study
medication) and yourself will not know which treatment group you belong to. However in case
of emergency, this information will be immediately available to your study doctor.
You will visit the study site for a physical exam and other assessments about 7 times during the
first 20 weeks of taking the study drugs (see the Visit Schedule below).
Your study participation will end if:
 Your condition has not improved at all by Visit 8 on Week 20 (5 months after study
treatment started), or
 You have not had sufficient improvement at Week 24, or
 You did not reach the state of sustained low disease activity at Week 52.
The definitions of “sufficient improvement” and of “low disease activity” are based on carefully
defined combinations of the number of swollen, tender joints, blood test results, and the subject’s
own assessment of how they feel.
If your study participation ends at any of these times, you will be asked to come back for the
Week 52 study visit.
Whenever your study participation ends, you should discuss other treatment options with your
doctor.
If your condition has improved at Week 52 and you have been in low disease activity for at least
3 months, the following options are possible:

If during the first year you were in the placebo + methotrexate group, in that case you
will continue to the same treatment when entering the second study year.

If during the first year you were in the study drug + methotrexate group, in that case you
will be randomly assigned to one of three treatment arms (see below) when entering the
second study year.
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Second study year: Week 52 to Week 104:
If you continue into the second year, you will be randomly assigned to one of three treatment
groups:

One active medication group (receiving 1 subcutaneous injection of 200mg
certolizumab pegol every 2 weeks in addition to methotrexate), or

Another active medication group (receiving 1 subcutaneous injection of 200mg
certolizumab pegol every 4 weeks in addition to methotrexate), or

The third group will receive placebo in addition to methotrexate.
You will have about a 7 out of 10 chance to be in one of the groups receiving certolizumab pegol
with methotrexate group and about a 3 out of 10 chance to be in the group receiving placebo with
methotrexate. Your assignment to one of the three groups will also be done randomly via a
computer system (see first study year).
If during the second year your condition worsens, meaning you have an increased disease
activity and you are not in low disease activity anymore, you may address this worsening at any
time to your doctor, not only during the study visits but also with a call to your study physician
who will organize an additional visit to examine you. If the worsening of your condition is
confirmed during a second visit two weeks later, you will receive certolizumab pegol until the
end of the study (last treatment at week 102).
In addition to the listed visits in the Visit Schedule below, you may be invited for additional
visits (called flare visits) to evaluate and treat the worsening of your symptoms (see below):
Flare Visits (Fx)
Evaluation of your
condition
Treatment
Flare visit 1
First
assessment of
worsening of
condition
Flare visit 2
second assessment
and confirmation
of worsening of
condition
Flare visit 3
Flare visit 4
Administration of
first dose 400 mg
CZP
Administration of
second dose 400 mg
CZP
Administration of
third dose 400 mg
CZP
Flare visit 5
Evaluation
of disease
activity
a.
Worsening of condition = you have an increased disease activity and you are not in low disease activity anymore.
b.
F2= F1+2weeks ; F3= F1+4weeks ; F4= F1+6weeks ; F5 = F1+12weeks (F=flare visit)
In total an additional 5 visits could be done depending if they overlap or not with those visits
shown in the Visit Schedule below. The assessments done at Week 6 as shown in the Visit
Schedule will also be done at these flare visits.
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If following this treatment your condition worsens a second time you will end your study
participation. Your treating physician will look for other treatment options.
Safety follow-up call:
After you finish the study, a safety follow-up call (10 weeks after the last administration of the
study medication) is performed to find out how you are feeling. This call is also done, if you
have been withdrawn from the study before Week 52 or Week 104.
Study procedures - Constraints
The Visit Schedule on the next pages gives you an overview of the visits you will have to attend
at the clinic when participating to this study. The table also provides you details on the
procedures that will be done at those visits as well as the questionnaires you will be asked to
complete.
Never hesitate to talk about any concern you may have to the study staff at the clinic if you have
any questions or feel uncomfortable.
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Week
W-2
W0
W2
W4
Visit Number
1
2
3
4
Obtaining your consent for study
participation and some
demographic data will be collected.
X
Visit Schedule
Your study doctor will ask for your
medical and medication intake
history (past diseases, intake of
last medications before study entry)
Your study doctor will ask for your
smoking status.
A standard physical examination,
including specific rheumatoid
arthritis assessments, and vital
signs (measurement of blood
pressure, heart rate, temperature,
height and weight), your doctor
may ask questions during several of
the listed visits.
To evaluate the presence of
tuberculosis a TB test and a chest
X-ray (if X-ray taken in the last 3
months is not available) will be
performed
The study doctor will go through a
set of questions to investigate the
tuberculosis risks during the study.
Blood and urine laboratory tests
will also be performed to ensure
that there are no safety issues.
Samples will also be collected to
evaluate the state of your
inflammation.
Pregnancy testing for female only
ECG (electrical tracing of heart
activity)
Baseline
Assessment
Screenin
g
WIRB APPROVED
AS MODIFIED
May 09, 2013
WIRB
Treatment Period
W6
5
W8
W12
W20
W24
W36
W40
W52
W64
W76
W84
W92
W104
6
7
8
9
10
11
12
13
14
15
16
17
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
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X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Created: 03-27-13
X
X
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X
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SFU
WIRB APPROVED
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Visit Number
The concentrations of the study
drug certolizumab pegol, will be
measured in the blood as well as
antibodies against the study drug.
You will be asked also to complete
some questionnaires related to your
disease and your quality of life,
which will be explained to you by
your study doctor. Your study
doctor will also complete some
questionnaires related to your
disease.
X-ray (hands, wrists and feet)
Your study doctor will ask for other
medications you take, or question
you on any events (eg, sickness)
that have occurred
Study Medication Administration
1
X
2
3
4
X
X
X
X
X
X
5
X
6
7
8
9
10
11
12
13
14
15
16
17
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
1.
X
In case you are taking anti malarial medication you will have to stop this medication to enter the study. The screening period before you may receive study drug will be prolonged up to 4
weeks.
2. Blood samples equal to 4-6 tablespoons of blood will be taken at the screening visit to test Hepatitis B antigens and antibodies, and Hepatitis C analysis. These blood samples will be also
used to perform specific rheumatoid arthritis tests for the evaluation of your disease.
3. The total amount of blood sampling during the study should not exceed 400 ml (±2/5 liter).
4. To allow proper analysis of the collected blood samples, you need to fast (no food or drink except for water) for 12 hours prior to your visit.
5. The questionnaires include questions asking you to rate your pain caused by your arthritis, how your arthritis is affecting your daily activities, your fatigue and your disease activity, in terms
of swollen and tender joints (i.e., shoulders, elbows, wrists, fingers, hips, knees, ankles and toes).
6. Health related questionnaires will include questions on your present and past condition in order to evaluate the improvement of your physical and mental health. There will be also questions
on your physical, social and emotional well-being as well as healthcare resource utilization questions (i.e., number of in-patient hospitalizations, out-patient visits, medical procedures and
home healthcare visits).
7. Each visit will last one to three hours.
8. If you leave the study before the end (at any time during the study), you will be asked to attend a last visit with the usual procedures as described in the W52 or W104 columns in the above
table. Also a safety follow up call will be performed 10 weeks after the last treatment administration. No study medication will be given at the withdrawal visit.
9. All details of what will happen during the study will be explained by your study doctor. Upon request, you may also ask your study doctor for a copy of the complete table with all study visit
assessments.
10. All assessments done at Week 20 will also be done during the flare visits.
11. Study medication will be taken at Week 20, Week 24 and Week 64 only if you continue in the study.
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AS MODIFIED
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EXPECTATIONS
If you decide to take part in this study, it is important to keep all scheduled appointments and to
tell the study doctor of any medical problems you have. You should tell the study doctor about
any other medications that you take, even if it is medicine that you buy without prescription.
During the first 3 treatment visits, the study nurse will provide you training on how to self
administer the study drug. In case you are unable to self‑administer the study drug a family
member, friend or caregiver may help you. You may also visit the site to receive the study
treatment administrations. In between all visits at your clinic, you will perform the
administration of study drug at home. You will be provided with the needed amount of study
drugs by the study nurse at your clinic visits. Please ensure you follow the treatment schedule
provided by your study doctor or staff. You should also ensure that the study drug certolizumab
pegol or placebo syringes are stored in your fridge and the MTX is stored at room temperature at
home. There are specific study drug storage requirements during travel and at home which your
study doctor or staff will discuss with you. You must return all used (empty syringes or
packages) and unused study drug.
If your arthritis gets worse while you are on the study, you and your study doctor may agree that
the best thing is to change your treatment. If this happens, any change of your anti-rheumatic
medication or in the dosage of your current medication should be discussed first with your study
doctor; it may be necessary for you to withdraw from the study.
Many vaccines are not recommended for patients treated with certolizumab pegol, however
inactivated flu and pneumococcal vaccines are allowed. You should discuss any proposed
vaccination with your study doctor, as well as any medication used during the study.
You may be required to take preventative treatment for tuberculosis, if your study doctor
determines that you meet the research study definition for being at increased risk for getting
active tuberculosis while taking certolizumab pegol. If your study doctor determines that you are
required to take preventative treatment for tuberculosis during your study participation, and you
are not compliant with the treatment, you may be withdrawn from the research study.
Pregnancy and Breastfeeding
The effects of the study treatment on the male and female reproductive system (such as sperm
and egg cell) on an unborn child are unknown.
You must not donate your reproductive cells (sperm or egg cell) for the time of participation in
this study and 3 months after taking the last dose of study treatment.
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Women
If you are a woman, you cannot take part in the study if you are pregnant, breast-feeding, or plan
to become pregnant during the study or within 3 months after taking the last dose of study
treatment. Pregnancy tests will be performed at most study visits, beginning with the screening
visit.
Women must have either had a tubal ligation or hysterectomy, be postmenopausal without a
menstrual period for at least 1 year, or be using an effective form of birth control starting at the
Screening Visit and continue to use birth control during the study and for at least 3 months after
taking the last dose of study treatment. Acceptable methods for preventing pregnancy include the
use of birth control pills, contraceptive (birth control) implant or injections; an intrauterine
device (IUD) and barrier methods with spermicide (condom or diaphragm with spermicidal
foam, cream or jelly). Abstinence (no sexual intercourse) only is not an acceptable method of
birth control for this study. Your study doctor will provide a list of acceptable methods of
contraception. If you become pregnant, you will be immediately withdrawn from the study to
prevent exposure of your unborn child to study treatment. The study doctor will ask your
permission to follow the outcome of the pregnancy, and if applicable, up to 30 days or more
following the birth of your baby.
Men
If you are a man and capable of fathering a child, you must use a latex condom every time you
have sexual intercourse with a female partner and you must not have unprotected sexual
intercourse with a female partner that could result in pregnancy starting at the Screening Visit
and continue to use birth control during the study and for 3 months after the last dose of study
treatment. You must ensure your female partner(s) use(s) adequate birth control.
If your partner becomes pregnant you must inform your study doctor of this pregnancy as soon
as possible. The study doctor will ask your partner’s permission to follow the outcome of the
pregnancy, and if applicable, up to 30 days or more following the birth of the baby.
NEW FINDINGS
During the course of the study, new information may become available about the study treatment
that is being studied. If this happens, your study doctor will inform you and discuss with you
whether you want to continue in the study. If you decide to withdraw from the study, your study
doctor will make arrangements for your care to continue. If you decide to continue in the study
you will be asked to sign an updated Subject Informed Consent Form.
DISCOMFORT AND RISKS
The study medication must be taken ONLY by the study subject. It must be kept out of the reach
of children and people who may not be able to read or understand the label.
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Methotrexate
Tell your study doctor promptly if you experience any of the following symptoms after taking
this medicine. Although they are rare, these symptoms can be serious.






Nausea (occurs very often at the start of the treatment).
Severe skin rash that causes blistering (this can affect the mouth and tongue). These may
be signs of a condition known as Stevens Johnson Syndrome. Your study doctor will
stop your treatment in these cases.
Persistent cough, pain or difficulty breathing or become breathless; MTX can cause
inflammation of the lungs.
Skin rash and fever with swollen glands, particularly in the first two months of treatment,
as these may be signs of excessive reaction of your body to methotrexate.
Sore, throat, fever, chills or achiness; methotrexate can make you more likely to catch
infections.
Severe allergic reaction (anaphylactic reaction) – although very rare you may experience
a sudden itchy skin rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or
throat (which may cause difficulty in swallowing or breathing), wheeze, and you may
feel you are going to faint. If this happens, you should seek medical attention
immediately.
Other side effects that may occur are:


















Drowsiness
Convulsions
Loss of coordination
Confusion
Liver damage (seen as yellowing of the skin and whites of the eye) including cirrhosis
(severe liver damage, a chronic degenerative disease in which normal liver cells are
damaged and are then replaced by scar tissue)
Kidney damage
Low blood levels of folic acid that could lead to anemia (low red blood cells)
Low levels of white and red blood cells and cells that clot blood
Infection, reduced resistance to infection
Abnormal red blood cell function
May encourage the development of diabetes
Inability to move, partial loss of voluntary movement
Inability to move in one half of the body
Dizziness
Headaches, blurred vision
Loss of ability to speak or understand speech
Slow thought process
Mood alteration, you may have unpredictable downs in your mood and feel anxious or
depressed
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Black or tarry stools
Skin ulcers and erosions of inflamed areas, in psoriasis patients
Damaged skin becomes inflamed on re-exposure to radiation and sunlight
Reduced ability to become pregnant and reduced ability to father children during and for
a short period after cessation of therapy with methotrexate
Blood in the urine
Raised liver enzymes due to damage to the liver during and for a short period after
cessation of therapy with methotrexate
Weakening or softening of bones
Unusual sensations in the head as a sign of nervous system disorder that result in high
sensitivity and feeling of heat or hot flashes
Anorexia (eating disorders)
Loss of interest in, or inability to have sex
Stomach pains and ulcers and soreness of the mouth, throat and lips
Inflamed blood vessels or superficial vein thrombosis which may impact the blood flow
and sometimes cause partial or full block of circulation and pain in inflamed sites
Feeling sick, vomiting, and/or diarrhea
Irritation or swelling of the vaginal tissues
Vaginal ulcers
Pain or difficulty in passing urine
The need to pass urine more often than usual
Joint and muscle pain
Chills and fever
Changes in skin coloration
Hair loss
Red spots on the skin, skin lesions, acne, boils
Flaking skin, redness
Itchiness and rash
Sensitivity to light
Eye irritation
Tiredness
General feeling of illness
Other metabolic changes. Methotrexate may impact liver and kidney functions and
thereby change your reactions to other drugs.
Respiratory fibrosis; development of scar tissue in lungs which can impact breathing.
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Certolizumab Pegol
To date, more than 12,104 subjects (including at least 463 healthy volunteers, 117 subjects with
psoriasis, 3,857 subjects with Crohn’s disease and 6,780 subjects with rheumatoid arthritis, 270
subjects with psoriatic arthritis and 200 subjects with axial spondyloarthritis) have received at
least one dose of certolizumab pegol. In addition, from information based on post-marketing
surveillance (from marketed certolizumab pegol), UCB Pharma SA estimates that more than
30,000 subjects with Crohn's disease or subjects with rheumatoid arthritis have received at least
one dose of certolizumab pegol (by prescription outside of research studies).
Side-effects possibly related to certolizumab pegol, reported through post-marketing
surveillance, are not different from those reported in the clinical studies. Side-effects that have
been found to be more common in subjects who took certolizumab pegol than those who took
placebo are:
 infections (such as lung, urine, and throat),
 bacterial and viral infections (including influenza, cold sores and shingles),
 headaches,
 hypertension (high blood pressure),
 back pain,
 rash,
 itching,
 fever,
 hepatitis (liver inflammation) including elevated liver enzymes,
 fatigue (feeling tired),
 leucopenia (low white blood cell count),
 sensory abnormalities (numbness, tingling or burning sensation), and
 injection site reactions.
Other more serious side effects resulting in hospitalizations or death also have occurred in
patients taking certolizumab pegol. These uncommon or rare events are discussed below.
Treatments that block TNF (tumor necrosis factor) might reduce the body’s ability to fight
infection. Subjects participating in studies with certolizumab pegol may have an increased risk of
developing infections. Some subjects in certolizumab pegol studies have developed infections
that have been serious or fatal (causing death). Many of the serious infections have occurred in
subjects taking other immunosuppressant medications (drugs that decrease the body's ability to
fight infections) such as methotrexate, azathioprine, or corticosteroids. Some serious infections
that have occurred in patients taking certolizumab pegol include tuberculosis (tuberculosis
infection in the lungs and/or spread throughout the body), sepsis (serious infection of the blood),
listeria infection (multi-organ serious infection), pyelonephritis (kidney infection) and
pneumonia (including atypical pneumonia such as legionella, pneumocystis). However, not all
were thought by the study doctor to be related to certolizumab pegol.
Particular fungal (yeast and mold) infections can possibly develop in subjects who are taking
drugs that block TNF like certolizumab pegol. These fungal infections are called opportunistic
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infections because they do develop in patients with immunodeficiency (decreased body’s ability
to fight infections) or who are treated with immunosuppressors (drugs that decreased the body's
ability to fight infections). These infections, although uncommon, can cause severe symptoms or
can even be fatal. Appropriate treatment should be administered rapidly. It is important to
diagnose those infections as soon as possible. You should tell your study doctor if you live or
have lived in or have traveled to an area with increased occurrence of these fungi, such as the
midwestern or southwestern regions of the USA (for example, for histoplasmosis, the Ohio or
Mississippi River Valley in the USA) or specific regions in South America. If you do not know if
the area you live in or if a place to which you have traveled is one where these fungal infections
are common, ask your study doctor. If you suspect you have these infections or if you get a
cough that does not go away, weight loss (6 kg/12 pounds within 6 months), tiredness, fever,
chills, chest pain, night sweats, shortness of breath, or any other signs of infection, tell your
study doctor and other health care providers right away.
The use of TNF blockers such as certolizumab pegol also may increase your risk for getting
active tuberculosis. In some subjects who received certolizumab pegol, the tuberculosis has been
fatal. In the interest of your safety, you may be required to take treatment for the prevention of
reactivation of latent (inactive) tuberculosis during your participation in this study. Subjects may
develop latent (inactive) asymptomatic (without symptoms) tuberculosis when they are exposed
to someone with active (symptomatic) tuberculosis. People with latent (inactive) tuberculosis
can develop active (symptomatic) of tuberculosis while being treated with a TNF blocker. Your
study doctor will determine whether you are required to begin treatment to prevent reactivation
of latent tuberculosis. Treatment for latent tuberculosis does not prevent the development of
active tuberculosis due to recent exposure to other people with active tuberculosis. You could
experience side effects from the use of medication taken to treat latent tuberculosis. Some
people who have taken medication for latent tuberculosis treatment have had the following side
effects:
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rash
hepatotoxicity (toxicity of the liver)
sideroblastic anemia (abnormal production of red blood cells)
peripheral neuropathy (damage to nerves)
If your study doctor determines that you are required to take preventative treatment for
tuberculosis during your study participation, and you are not compliant with the treatment, you
may be withdrawn from the research study.
Your study doctor will determine the most appropriate treatment for you, if you are required to
take treatment for latent tuberculosis.
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The US Food and Drug Administration (FDA) has issued a warning that certain types of cancers
called lymphoma and leukemia have been reported in patients taking TNF blockers. Both
leukemia and lymphoma are types of blood cancers. In general, people with rheumatoid arthritis,
are more likely to develop lymphoma and leukemia than people in the general population. The
risk of developing these and other cancers may also be increased with medicines that block TNF,
including certolizumab pegol. Patients with moderate to severe chronic obstructive pulmonary
disease (COPD), or who are heavy smokers, may be at increased risk for cancer (lung, head or
neck) when using anti-TNF therapy.
Cases of cancer have been reported in subjects treated with certolizumab pegol, but it is not
known if these cases were in any way related to taking certolizumab pegol. It is not possible to
say what the risk of you developing a cancer is but it is important that you are aware of the
possible risk with certolizumab pegol. You should have been given the opportunity to discuss
this risk with your study doctor, after which you should decide whether or not you want to
continue in the study. If you decide that you do not want to continue then you may discuss
alternative treatment with your study doctor.
In addition, cases of non-melanoma skin cancer have been observed in patients taking
certolizumab pegol. If new skin lesions (abnormalities) appear during or after therapy with
certolizumab pegol or existing skin lesions change appearance, tell your study doctor.
There is a risk of congestive heart failure (CHF), including new heart failure or worsening of
heart failure, with treatments that block TNF, including certolizumab pegol. If you develop
symptoms of shortness of breath, swelling of your ankles or feet, or sudden weight gain, you
should tell your study doctor.
You may have an allergic reaction to certolizumab pegol. Signs of a serious allergic reaction may
include a skin rash, swelling of the face, tongue, lips, or throat, or trouble breathing. Severe
allergic skin reactions have also been reported rarely with other TNF blockers. It is not clear
what the risk of developing them are with certolizumab pegol.
In addition there is a risk that if you have had hepatitis B (liver infection) in the past, TNF
blockers may reactivate the infection. Tell your study doctor if you develop or have any
worsening of the following symptoms: malaise (feeling unwell), poor appetite, tiredness, fever,
skin rash, or joint pain.
There is also a risk of developing new or worsening of nervous system problems such as
peripheral demyelinating disorders, including Guillain-Barré syndrome (inflammatory disease
with damage of the protective sheath of the peripheral nerve), multiple sclerosis (inflammatory
disease of the central nervous system), seizures or inflammation of the nerves of the eye
reported with TNF blockers like certolizumab pegol. Tell your study doctor if you develop any
symptoms of dizziness, numbness or tingling, problems with your vision or hearing, or weakness
in your arms or legs.
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Reports of low blood cell counts such as anemia (low red blood cell count), thrombocytopenia
(low platelet counts) and pancytopenia (all blood cell counts low) have been reported in patients
taking TNF blockers including certolizumab pegol. Tell your study doctor if you develop
symptoms of bruising, bleeding very easily, fever, or paleness.
Certolizumab pegol treatment may be associated with the development of immune reactions such
as a lupus-like syndrome, alopecia (hair loss), new onset or worsening of psoriasis (scaly skin
rash, sometimes with acne), erythema nodusum (patchy or nodular inflammation of the fat cells
under the skin of the shin), sarcoidosis (general respiratory disorder), vasculitis (inflammation of
the blood vessels) and uveitis (inflammation of the eye). Tell your study doctor if you develop
any new symptoms including shortness of breath, joint pain, vision trouble, or a rash. These
conditions may or may not be associated with the development of autoantibodies (proteins in the
blood directed against your own body). Some subjects who received certolizumab pegol did
develop these autoantibodies, although at this time their study doctors do not feel that this was
associated with any adverse effects (side effects).
The impact of long-term treatment with certolizumab pegol on the development of autoimmune
diseases is unknown.
Another type of antibody that can occur in subjects who take medicines like certolizumab pegol
is an antibody to certolizumab pegol (a protein in the blood directed to certolizumab pegol). So
far no significant side effects associated with this finding have been seen. However, in some of
these subjects with antibodies to certolizumab pegol, the blood levels of certolizumab pegol are
lower than in those subjects who do not develop these antibodies. In some of these subjects, it is
thought that the lower levels of certolizumab pegol may have affected how well certolizumab
pegol worked in treating their disease. It is not known if there are any long-term effects
associated with developing these antibodies.
Other serious or significant side effects reported on certolizumab pegol include:
 arrhythmias (abnormal heart rhythms) including atrial fibrillation,
 ischemic cardiovascular and cerebrovascular disease (such as heart attack and stroke),
 pericarditis (inflammation of the heart lining with or without fluid),
 gastrointestinal ulceration/perforation (holes in esophagus, stomach, and intestines or
gut),
 hepatitis (liver inflammation, increased liver enzymes),
 gallstones,
 intestinal (gut) obstruction (blockage),
 hemorrhage (abnormal bleeding),
 thrombophlebitis (blood clots in the veins),
 thrombocytosis (increased platelets),
 anxiety,
 bipolar disorder (mood disorder),
 suicide attempt,
 nephrotic syndrome (kidney disease), and
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 renal (kidney) failure.
Side effects of certolizumab pegol that are unknown at this time could occur. Unknown side
effects may involve risks to you, and for women who become pregnant, unknown risks may
affect an embryo or unborn child. Women who have become pregnant while taking certolizumab
pegol have experienced the following events: miscarriage (spontaneous abortion), baby smaller
than expected for the duration of the pregnancy, fetal distress syndrome (stress of the baby
during the pregnancy or delivery); premature baby (baby born earlier than expected); however
most of the babies born were healthy babies. It is not known at this time to what extent, if any,
therapy with certolizumab pegol was associated with any of these problems. Therefore, if you
are a woman who may be able to become pregnant, you must not become pregnant during the
study and you must continue contraceptive precautions for at 10 weeks after the last injection of
certolizumab pegol.
Rare cases of azoospermia (no measurable level of sperm) have also been reported in male
patients taking TNF blockers including certolizumab pegol.
No information is available on the effects of certolizumab pegol on the ability to drive and use
machines.
Risks associated with procedures
PPD Tuberculosis: A needle will be placed just under the skin to inject a small amount of PPD
fluid. Inserting a needle under the skin may result in mild pain, bleeding and a change in skin
color or bruising, and/or an infection from the needle stick. If you have been exposed to the
tuberculosis (TB) germ, the area of the skin where the fluid is placed may or may not become red
and/or rise for several days. If you have a positive PPD skin test, you may experience pain,
itching, redness, firmness and swelling at the site of the skin test. This test must be seen and
interpreted by the study staff between 48 and 72 hours of injection during a visit.
Injection: Localized pain, bleeding, bruising or infection can occur at the site where injections
are given.
Blood Collection: Possible side effects from blood collection include faintness, inflammation of
the vein, pain, bruising, or bleeding at the site of puncture. There is also a slight possibility of
infection.
X-Ray: The risk associated with radiation exposure from having an x-ray of chest, hands, wrists
and feet is minimal. A typical x-ray will deliver a small amount of radiation, about the same
amount of radiation you would receive in nature over 10 days or flying cross-country in an
airplane. Although all radiation is cumulative over your lifetime, small doses from x-rays should
not be significant.
Fasting: Fasting for 12 hours could cause dizziness, headache, stomach discomfort, or fainting.
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Electrocardiogram (ECG): An electrocardiogram is a safe procedure. The risk of electrocution
during an electrocardiogram does not exist. The electrodes placed on your body do not emit
electricity but only record the electrical activity of your heart. There may be minor discomfort,
similar to removing a bandage, when the electrodes taped to your chest are removed. Rarely, a
reaction to the electrodes may cause redness or swelling of the skin.
Washout: If you are asked to stop taking antimalarials during the screening period, you will not
be receiving regular doses of active medication to treat your rheumatoid arthritis and your
symptoms may worsen, stay the same or improve.
There is a risk that certolizumab pegol might not work for you or might not work as well as
another medicine. Your condition may not get better or may become worse during this study.
If a subject taking part in this study, or any other study with certolizumab pegol, develops a
significant medical problem or problems, or if new information becomes available that may be
relevant to your willingness to continue on the study, we will tell you. We will also update this
information sheet periodically, and will give you a copy.
If you have private medical insurance please check with your insurance company before
agreeing to take part in the study. You should do this in order to ensure that your participation
will not affect your medical insurance.
If your study doctor becomes aware of any new conditions associated with certolizumab pegol
during the course of the study, your doctor will inform you of those conditions and if you agree,
your family doctor will also be informed.
ALTERNATIVE PROCEDURES AND/OR TREATMENT
If you decide to not enter the study, other FDA approved treatments are available to treat
rheumatoid arthritis including certolizumab, methotrexate, other anti-rheumatic drug(s) and other
anti-TNF products. The study doctor will be able to provide you with more information about
these treatments.
If, at any time during the study you want to withdraw, your study doctor will look for the most
appropriate treatment for your rheumatoid arthritis disease.
BENEFITS
Certolizumab pegol may be beneficial in treating your condition and may improve your
symptoms, but this cannot be guaranteed.
While you may not personally benefit from being in this study, the information learned from this
study may help researchers to find out if certolizumab pegol will help other people with
rheumatoid arthritis.
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You may not have a direct health benefit from participating in this study.
COST
Study medication will be provided at no cost to you by UCB Pharma SA during your
participation in this study. Any procedures or treatment that are considered to be standard of
care for your underlying condition will be billed to your insurance and will be your responsibility
if your insurance company does not pay for the costs Study related medical examinations will
also be provided at no cost to you.
If you are in Medicare Advantage (Medicare managed care plan), you should contact someone at
your plan before you start a clinical trial. They can provide more information about additional
costs you could incur from participating in clinical trials.
QUESTIONS
If you have any questions about this study or your participation in this study or if at any time you
feel you have experienced a research-related injury, medical emergency or a reaction to the study
medication, contact:
Dr. Jeffrey R. Curtis at 205-934-7727 or 205-934-3411 (24-hour pager)
If you have questions about your rights as a research subject or if you have questions, concerns or
complaints about the research, you may contact:
Western Institutional Review Board® (WIRB®)
3535 Seventh Avenue, SW
Olympia, Washington 98502
Telephone: 1-800-562-4789 or 360-252-2500
E-mail: Help@wirb.com
Or
You may also contact the Office of the Institutional Review Board for Human Use (OIRB) at the
University of Alabama at Birmingham at (205) 934-3789 or 1-800-822-8816. If calling the tollfree number, press the option for “all other calls” or for an operator/attendant and ask for
extension 4-3789. Regular hours for the Office of the IRB are 8:00 a.m. to 5:00 p.m. CT,
Monday through Friday. You may also call this number in the event the research staff cannot be
reached or you wish to talk to someone else.
WIRB is a group of people who perform independent review of research.
WIRB will not be able to answer some study-specific questions, such as questions about
appointment times. However, you may contact WIRB if the research staff cannot be reached or
if you wish to talk to someone other than the research staff.
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AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH
PURPOSES
Federal regulations give you certain rights related to your health information. The purpose of
this form is to obtain your permission regarding who will be able to get information and why
they may be able to get it. The study doctor must get your authorization (permission) to use or
give out any health information that might identify you.
Biological samples may be collected, processed, and reported as necessary for purposes of the
Study. Blood samples will be taken at each study visit and shipped the same day or the day after
to the central laboratory. At the central laboratory the samples will be analyzed or stored until
analysis. In all cases the samples will be analyzed before the end of the study. All blood samples
shipped from the study clinic will not bear your name but only a number.
In the event anyone involved with this Study is exposed to your blood or bodily fluids, your
blood may be tested for evidence of hepatitis, AIDS, or other infections without your further
consent.
What information may be used and given to others?
If you choose to be in this study, the study doctor will get personal information about you. This
may include information that might identify you. The study doctor may also get information about
your health including:
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Past and present medical records
Research records
Records about phone calls made as part of this research
Records about your study visits.
Information obtained during this research about
Other reportable infectious diseases such as TB
Physical exams
Laboratory, x-ray, and other test results
Diaries and Questionnaires
Records about any study drug you received
If you receive services in University Hospital as part of this trial, this consent form will be placed
in and made part of your permanent medical record at the hospital.
Who may use and give out information about you?
Information about your health may be used and given to others by the study doctor and staff.
They might see the research information during and after the study.
Who might get this information?
Your information may be given to the sponsor of this research. “Sponsor” includes any persons
or companies that are working for or with the sponsor, or are owned by the sponsor.
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For this study, “sponsor” also includes PAREXEL, an agent for the sponsor.
Information about you and your health, which might identify you, may be given to:
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The U.S. Food and Drug Administration (FDA),
Department of Health and Human Services (DHHS) agencies,
Governmental agencies in other countries,
Governmental agencies to whom certain diseases (reportable diseases) must be reported,
The University of Alabama at Birmingham - The physicians, nurses and staff working
on the research protocol (whether at UAB or elsewhere); other operating units of
UAB, University of Alabama Health Services Foundation, The Children’s Hospital of
Alabama, Callahan Eye Foundation Hospital and the Jefferson County Department of
Public Health, as necessary for their operations; the UAB IRB and its staff.
Western Institutional Review Board® (WIRB®)
The billing offices of UAB and UAB Health Systems affiliates
Why will this information be used and/or given to others?
Information about you and your health that might identify you may be given to others to carry
out the research study. The sponsor will analyze and evaluate the results of the study. In
addition, people from the sponsor and its consultants will be visiting the research site. They will
follow how the study is done, and they will be reviewing your information for this purpose.
The information may be given to the FDA. It may also be given to governmental agencies in
other countries. This is done so the sponsor can receive marketing approval for new products
resulting from this research. The information may also be used to meet the reporting
requirements of governmental agencies. If your medical record needs to be reviewed by a
foreign regulatory agency, a member of the UAB IRB staff will be present at the review of your
medical record to ensure that the medical record is not removed; copied or identifiable
information is recorded in any manner.
The results of this research may be published in scientific journals or presented at medical
meetings, but your identity will not be disclosed.
The information may be reviewed by WIRB®. WIRB is a group of people who perform
independent review of research as required by regulations.
Information relating to this study, including your name, medical record number, date of birth and
social security number, may be shared with the billing offices of UAB and UAB Health System
affiliated entities so that claims may be appropriately submitted to the study sponsor or to your
insurance company for clinical services and procedures provided to you during the course of this
study.
The results of this research may be published in scientific journals or presented at medical
meetings, but your identity will not be disclosed.
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®
The information may be reviewed by WIRB . WIRB is a group of people who perform
independent review of research as required by regulations.
What if I decide not to give permission to use and give out my health information?
By signing this consent form, you are giving permission to use and give out the health
information listed above for the purposes described above. If you refuse to give permission, you
will not be able to be in this research.
May I review or copy my information?
You have the right to review and copy your health information. However, if you decide to be in
this study and sign this permission form, you will not be allowed to look at or copy your
information until after the research is completed.
May I withdraw or revoke (cancel) my permission?
Yes, but this permission will not stop automatically. The use of your personal health information
will continue until you cancel your permission.
You may withdraw or take away your permission to use and disclose your health information at
any time. You do this by sending written notice to the study doctor. If you withdraw your
permission, you will not be able to continue being in this study.
When you withdraw your permission, no new health information about you will be gathered after
that date. Information that has already been gathered may still be used and given to others.
Is my health information protected after it has been given to others?
If you give permission to give your identifiable health information to a person or business, the
information may no longer be protected. There is a risk that your information will be released to
others without your permission.
PAYMENT FOR PARTICIPATION
You will be paid $30 for each completed visit. You will also be reimbursed $5 for parking. You
will be paid after each completed visit.
COMPENSATION FOR INJURY
In the event of a physical injury resulting from taking the Study Drug or any procedure required
by the Protocol during your participation in the study, UCB agrees to pay, according to insurance
subscribed to by UCB, medical expenses necessary to treat such injury 1) to the extent that you
were not otherwise reimbursed by medical insurance and 2) provided that you have followed the
directions of the study doctor. No other compensation will be offered. Any injury believed to be
caused by the study drug must be reported promptly to the study doctor.
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UAB has not provided for any payment if you are harmed as a result of taking part in this study.
If such harm occurs, treatment will be provided. However, this treatment will not be provided
free of charge.
You will not lose any of your legal rights or release the sponsor, the study doctor, the study staff,
or study site from liability for mistakes or intentional misconduct by signing this consent
document.
If you are injured during this study, your study doctor will discuss with you the available medical
treatment options.
VOLUNTARY PARTICIPATION/WITHDRAWAL
Your participation in this Study is voluntary. You may choose to not participate or you may
withdraw from the study, for any reason, without penalty or loss of benefits to which you are
otherwise entitled and without any effect on your future medical care.
The study doctor or UCB or designee can stop your participation at any time without your
consent for the following reasons:
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if it is in your best interest;
if it appears to be medically harmful to you;
if you fail to follow directions for participating in the study;
if it is discovered that you do not meet the study requirements, including if something
serious happens to you which may require treatment;
you do not consent to continue in the study after being told of changes in the research that
may affect you;
if the study is canceled;
for administrative reasons, including not enough subjects in the study:
or for any other reason.
If you leave the study early, for any reason, you will be asked to return to the study center to
have the Visit 12 or Visit 17 and the safety follow up tests and procedures.
If you withdraw from the Study, you have the right to have all retained samples destroyed and
not used for future analysis. To have all retained samples destroyed, you must notify your Study
doctor in writing.
SOURCE OF FUNDING FOR THE STUDY
UAB is being paid by UCB Pharma SA to conduct this research.
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Subject Initials __________
APPROVED
AS MODIFIED
May 09, 2013
WIRB
STATEMENT OF CONSENT
I have read the information in this consent form. All my questions about the study and my
participation in it have been answered. I freely consent to be in this research study.
I □ agree – □ do not agree – that my General Practitioner can be informed of my participation
in this research study. (Please tick the appropriate box.)
YES
NO: I authorize the use and disclosure of my health information to the parties listed in
the authorization of this consent for the purposes described above. (Please tick the appropriate
box)
I understand I will receive a copy of this consent form, signed and dated.
By signing this consent form, I have not given up any of my legal rights.
______________________________________
Subject Name
CONSENT SIGNATURE:
______________________________________
Subject’s Signature
________________________
Date
______________________________________
Witness Name
______________________________________
Witness
Signature of Person Conducting Informed
Consent Discussion
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________________________
Date
Date
Subject Initials __________
APPROVED
AS MODIFIED
May 09, 2013
WIRB
Attestation Statement
I confirm that the research study was thoroughly explained to the subject. I reviewed the consent
form with the subject and answered the subject’s questions. The subject appeared to have
understood the information and was able to answer the following questions correctly:
1.
2.
3.
4.
5.
6.
7.
8.
What is the purpose of this study?
If you decide to be in the study, what will you be asked to do?
What is the possible benefit of participating in this study?
What are the possible risks of participating in this study?
If you decide not to participate in this study, what options do you have?
Will participating in this study cost you anything? If so, what will you have to pay for?
Do you have to be in this study?
If you decide to be in the study, can you leave the study when you want to?
________________________________________
Printed Name of Person Conducting the
Informed Consent Discussion
__________________
Position
________________________________________
Signature of Person Conducting the
Informed Consent Discussion
__________________
Date
Created: 03-27-13
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Subject Initials __________