APPROVED
AS MODIFIED
Mar 28, 2013
WIRB
SL0012
UCB, Inc., Smyrna, Georgia, United States
SL0012
20111247
W110728004
TITLE:
RESEARCH SUBJECT INFORMATION AND CONSENT FORM
A PHASE 3, MULTICENTER, OPEN-LABEL, EXTENSION STUDY
TO ASSESS THE SAFETY AND TOLERABILITY OF
EPRATUZUMAB
TREATMENT
IN
SYSTEMIC
LUPUS
ERYTHEMATOSUS SUBJECTS (EMBODY 4)
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.




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.
Created: 03-07-2013
Page 1 of 25
Subject Initials
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SL0012
RESEARCH SUBJECT INFORMATION AND CONSENT FORM
TITLE:
A PHASE 3, MULTICENTER, OPEN-LABEL, EXTENSION
STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF
EPRATUZUMAB TREATMENT IN SYSTEMIC LUPUS
ERYTHEMATOSUS SUBJECTS (EMBODY 4)
PROTOCOL NO.:
SL0012
WIRB® Protocol #20111247
W110728004
SPONSOR:
UCB, Inc.
INVESTIGATOR:
W. Winn Chatham, M.D.
SRC 076
1717 6th Ave South
Birmingham, Alabama 35294
United States
SITE(S):
University of Alabama at Birmingham
SRC 076
1717 6th Avenue South
Birmingham, Alabama 35294
United States
STUDY-RELATED
PHONE NUMBER(S):
Created: 03-07-2013
W. Winn Chatham, M.D.
866-876-2247
205-934-3411 (24 hour pager)
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SL0012
You have been asked to take part in a clinical research study initiated, managed, and financed by
UCB Inc., the Sponsor of this study.
Before agreeing to participate in this study, you need to understand why the research is being
done and what it will involve. This consent form describes the purpose, procedures, potential
benefits, risks, discomforts, and precautions of the study. Please read each page of this consent
form so that you can make an informed decision about your participation and ask your study
doctor or the study staff to explain any words, terms or information that you do not clearly
understand. Please discuss any questions you may have with the study doctor or study staff.
Once you understand the information, you must sign this consent form if you want to take part in
the study. Study related procedures cannot be performed if your signature is not received. If you
choose to take part in this study, a copy of the signed and dated consent form will be given to
you.
Please give an accurate account of your health history to your study doctor. If you are not
completely truthful with your study doctor regarding your health history, you may harm yourself
by participating in this study.
If you have a personal or primary care doctor, we ask that you inform him/her if you decide to
participate in this study.
PURPOSE OF THE STUDY
The purpose of this study is to assess the safety and tolerability of long-term epratuzumab
treatment in subjects with lupus. Epratuzumab is an investigational (new) drug that has not yet
been approved by the United States Food and Drug Administration (FDA) or any European
Medicines Agencies.
To find out if epratuzumab will help or continue to help in reducing the symptoms in lupus
patients, all subjects participating in this study will be assigned to one of the following treatment
groups:
 600 milligrams (mg) of epratuzumab weekly for a total of 4 weeks (total dose of 2400mg)
over eight 12-week treatment cycles.
 1200 milligrams (mg) of epratuzumab twice in 4 weeks (every other week for a total dose
of 2400mg) over eight 12-week treatment cycles.
This means that during the course of the study you can be treated with epratuzumab up to 16
times if you are in the 1200mg group or 32 times if you are in the 600mg group.
Created: 03-07-2013
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Whether you are assigned to the 600mg treatment group of epratuzumab or the 1200mg treatment
group of epratuzumab will be determined at random (like flipping a coin). This will be
automatically determined by a computer system. You have a 1 out of 2 or a 50% chance of being
assigned to the 600mg treatment group and a 1 out of 2 or 50% chance of being assigned to the
1200mg treatment group.
Epratuzumab will be given to you by slow intravenous infusion. This means that a needle will be
inserted into a vein in your arm. The needle will then be attached to a plastic tube and plastic bag
containing epratuzumab. The contents (epratuzumab) of the plastic bag will then drip through the
plastic tube and into the needle in your arm. Each infusion will last about 1 hour.
In order to try to minimize possible reactions to the infusion with the study drug, it is
recommended that acetaminophen (a pain reliever) and diphenhydramine (an antihistamine given
to prevent and/or treat allergic reactions) are administered to you prior to receiving each infusion.
If your study doctor determines that it is in your best interest not to use diphenhydramine, an
alternate antihistamine will be given to you prior to receiving study drug (epratuzumab).
During the study, it is allowed to a certain extent to treat your lupus symptoms with drugs other
than the study drug or to continue ongoing treatment with such drugs. However, additional
treatment with these drugs is only allowed up to certain doses. If you wish to know more about
these dose allowances, please ask your study doctor.
Approximately 1400 subjects with lupus will be treated with study drug, in up to 300 study sites
in approximately 30 countries.
DESCRIPTION OF THE STUDY
You are being asked to take part in this study because you participated in a previous double-blind
study (either SL0009 or SL0010) or a previous open-label extension study (either SL0006 or
SL0008) and the study doctor feels that you are an appropriate subject for this study. The goal of
this clinical research study is to assess the safety and tolerability (to take with no bad effect) of
the long-term treatment of epratuzumab, an investigational (new) drug, in reducing signs and
symptoms of lupus. Lupus is an autoimmune disease, which is an illness that occurs when the
body tissues are attacked by its own immune system (the system that protects against foreign
substances in the body). It can affect various parts of the body such as the kidneys, heart, lungs
and brain. Symptoms may include extreme fatigue, joint and muscle pain, eye problems,
depression, mouth ulcers, facial or other rashes, hair loss and anemia (lack of healthy red blood
cells).
Created: 03-07-2013
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The immune system in people with lupus cannot tell the difference between foreign substances
and the body’s own cells and tissues. In lupus, the immune system makes antibodies (proteins
that detect and destroy foreign substances in the body), and these antibodies then fight against the
body’s cells and tissues, causing inflammation. Inflammation may include pain, heat, redness,
swelling and loss of function and can be on the inside and/or the outside of the body.
Inflammation is considered the primary feature of lupus. Epratuzumab is believed to work, in
part, by changing how B-cells (a type of white blood cell that produces antibodies, which detect
and destroy foreign substances in the body) work and/or by reducing their number in the body,
which may prevent the immune system from attacking healthy organs and thus reduce the level
of inflammation.
For most people, lupus is a mild disease affecting only a few organs. For others, it may cause
serious and even life-threatening problems. More than 90 percent of people with lupus are
women. Symptoms and diagnosis occur most often when women are in their child-bearing years,
between the ages of 15 and 45. Worldwide, conservative estimates are that over 5 million people
have lupus.
Epratuzumab has been administered in 18 sponsored clinical studies to date; 8 studies in
oncology (cancer) indications and 10 studies in autoimmune diseases (7 of these studies were
specifically for the treatment of systemic lupus erythematosus, including the SL0006, SL0008,
SL0009 and SL0010 studies).
PROCEDURES
If you agree to participate in this study, your involvement could last approximately 100 weeks or
about 2 years and could involve up to 42 visits to your study doctor's office or clinic. The total
number of your visits to the clinic will depend on which treatment group you are in and how long
you stay in the study.
You will be asked to attend your study doctor’s office or clinic at the study entry visit
(Visit
1). During this visit, your eligibility for enrollment into SL0012 will be determined. The results
from the procedures performed at the End of Treatment Visit or the Early Withdrawal Visit in
SL0009 or SL0010 may be used, if performed within 4 weeks of Visit 1 in SL0012. The
procedures include the collection of blood samples, questionnaires that you are asked to
complete, and lupus assessments performed by your study doctor. All subjects completing
studies SL0006 or SL0008 must complete all Visit 1 assessments in SL0012.
If you qualify to enroll in SL0012, you will be assigned to one of the two treatment groups and
you will be given treatment at Visit 1.
Created: 03-07-2013
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
If you are assigned to the 600mg treatment group, you will come into the study doctor's
office or clinic every week for four consecutive weeks to receive epratuzumab. After the
fourth infusion visit, you will return to the study doctor’s office in one week for a followup visit, where no epratuzumab is given. A telephone contact will occur four weeks after
the follow-up visit. The schedule of study visits will repeat every 12 weeks for
approximately of 96 weeks.
 If you are assigned to the 1200mg treatment group, you will come into the study doctor's
office every other week to receive epratuzumab twice within 4 weeks. After the second
infusion visit, you will return to the study doctor’s office in two weeks for a follow-up
visit, where no epratuzumab is given. A telephone contact will occur four weeks after the
follow-up visit. The schedule of study visits will repeat every 12 weeks for
approximately 96 weeks.
After you finish the last 12-week treatment cycle, you will have your End of Treatment Visit
(Week 96). A Safety Follow-up Visit will be performed four weeks after the End of Treatment
Visit (Week 100).
If you leave the study early, you will be asked to complete an Early Withdrawal Visit. In
addition, you will be asked to return to your study doctor's office or clinic 13 weeks after your
last infusion of epratuzumab for a Safety Follow-up Visit.
The table below shows how the treatment cycles work and the last visits performed: The two
columns on the right show when infusions would be given based on which treatment group you
are assigned.
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SL0012
Treatment
Cycle
1
Visit or Telephone contact
Time Frame After Previous
Visit
0 weeks (Study Entry)
1
1 week
2
1 week
3
1 week
4
1 week
5
4 weeks
5a Telephone Contact
4 weeks
2
6
1 week
7
1 week
8
1 week
9
1 week
10
4 weeks
10a Telephone Contact
3 through Treatment Cycles 3 through 8 will be similar to Treatment Cycle
8
above. The treatment cycles include Visits 11 (Week 24) through
Telephone Contact 40a. at Week 92.
41
(End
of
Treatment/Early End of Treatment: 4 weeks after
the previous telephone contact
Withdrawal)
Early Withdrawal: Upon your
withdrawal
13 weeks after last infusion
42 (Safety Follow-up)
600mg
Infusion
X
X
X
X
1200mg
Infusion
X
X
X
X
X
No visit
X
No visit
X
No visit
X
No visit
2 shown
the final
Below you will find detailed information about the procedures done at each study visit.
Visit 1
Enrollment:
Before any study-related tests and procedures are performed, you will be asked to read and sign
this Informed Consent Form and any authorization forms (as applicable). This visit will be
performed for both treatment arms. Your study doctor and/or study staff will be performing the
following tests and procedures upon entry into the SL0012 study:






Determine your eligibility by reviewing study entry requirements.
Collect your demographic (personal) information (date of birth and gender).
Ask you to mark on a scale how active you feel your lupus disease is at the moment.
Review with you your past and current medications including medicines you buy without a
prescription.
Measure your weight.
Measure your vital signs (blood pressure, pulse rate, and body temperature). Your vital signs
will be measured several times during this visit.
Created: 03-07-2013
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SL0012







Collect blood and urine samples for laboratory testing. Approximately 7 teaspoons of blood
will be needed. For females who may be able to become pregnant, this includes a urine
pregnancy test. The result of the pregnancy test must be negative (show that you are not
pregnant) for you to participate in this study.
Collect additional blood (approximately 1 teaspoon) to determine the levels of possible
antibodies against epratuzumab in your blood.
Perform lupus assessments.
Provide you with questionnaires to complete that will ask about your physical and emotional
well being, your social life and quality of life, your lupus symptoms and your level of fatigue.
Ask about how you have been feeling and if you have had any medical procedures.
Ask if you have recently been to an emergency room or if you have been hospitalized.
Assignment to either 600mg or 1200mg treatment arm and administration of epratuzumab
(study drug).
This visit may take up to 3 or more hours. You may be asked to stay at the study doctor’s office
or clinic a little longer after all of the visit procedures are completed in order to be observed.
This is to ensure that you are well enough to leave the study doctor's office or clinic.
If you are eligible to participate in this study, your study doctor or site designee will give you a
Subject Identification (ID) Card. You will keep the Subject ID Card with you during the study. In
case of any emergency situation, healthcare professionals can contact the UCB study physician to
obtain information about epratuzumab or your participation in this trial. The emergency contact
information will be provided on the Subject ID Card.
Visits 6, 11, and 16 [Year 1]
Visits 21, 26, 31, and 36 [Year 2]
First Infusion Visits: for
600mg
and
1200mg
treatment groups:
The study visits listed above are similar and will be performed for both treatment arms. Below
describes what will occur at the first infusion visits of each of the remaining 12-week treatment
cycles. Your study doctor and/or study staff will:




Ask about any medications you are currently taking, including those you buy without a
prescription.
Ask you to mark on a scale how active you feel your lupus disease is at the moment.
Measure your weight.
Measure your vital signs (blood pressure, pulse rate, and body temperature). Your vital
signs will be measured several times during this visit.
Created: 03-07-2013
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






Collect blood and urine samples for laboratory testing. At Visits 6, 16, 26, and 36,
approximately 4½ teaspoons of blood will be needed. At Visits 11 and 31, approximately
5½ teaspoons of blood will be needed. At Visit 21, approximately 7 teaspoons of blood
will be needed. For females who may be able to become pregnant, this includes a urine
pregnancy test. The result of the pregnancy test must show that you are not pregnant for
you to continue participating in this study.
Collect additional blood (approximately 1 teaspoon) to determine the levels of possible
antibodies against epratuzumab in your blood.
Perform lupus assessments.
Provide you with questionnaires to complete that will ask about your physical and
emotional well being, your social life and quality of life, your lupus symptoms and your
level of fatigue (performed at Visits 11, 21, and 31 ONLY).
Ask about how you have been feeling and if you have had any medical procedures.
Ask if you have recently been to an emergency room or have been hospitalized since your
last study visit.
Administer epratuzumab (study drug).
These visits may take up to 3 or more hours. You may be asked to stay at the study doctor’s
office or clinic a little longer after all of the visit procedures are completed in order to be
observed. This is to ensure that you are well enough to leave the study doctor's office or clinic.
Visits (2, 3, 4) (7, 8, 9) (12, 13, 14) (17, 18, 19) [Year 1]
Visits (22, 23, 24) (27, 28, 29) (32, 33, 34) (37, 38, 39) [Year 2]
Visits (3, 8, , 18) [Year 1]
Visits (23, 28, 33, 38) [Year 2]
Infusion
Visits:
(600mg treatment arm)
Infusion Visits (1200mg
treatment arm):
The study visits listed above are similar. Below describes what will occur at the above listed
infusion visits for each of the 12-week treatment cycles. The treatment group you are assigned to
will determine the number of visits and the number of infusions you receive. During the visits
listed above your study doctor and/or study staff will:

Ask about any medications you are currently taking, including those you buy without a
prescription.
 Measure your vital signs (blood pressure, pulse rate, and body temperature). Your vital
signs will be measured several times during this visit.
 Collect a urine sample for a pregnancy test (females who may be able to become pregnant
only). The result of the pregnancy test must show that you are not pregnant for you to
continue participating in this study.
 Ask about how you have been feeling and if you have had any medical procedures.
 Ask if you have recently been to an emergency room or have been hospitalized since your
last study visit.
 Administer epratuzumab (study drug).
Created: 03-07-2013
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SL0012
These visits may take up to 2 or more hours. You may be asked to stay at the study doctor’s
office or clinic a little longer after all of the visit procedures are completed in order to be
observed. This is to ensure that you are well enough to leave the study doctor's office or clinic.
Visits 5, 10, 15, and 20 [Year 1]
Visits 25, 30, 35, and 40 [Year 2]
Non-Infusion Visits:
The study visits listed above are similar and apply to both treatment arms. Below describes what
will occur at the non-infusion visits (Week 4) of each of the 12-week treatment cycles. Your
study doctor and/or study staff will:

Ask about any medications you are currently taking, including those you buy without a
prescription.
 Measure your vital signs (blood pressure, pulse rate, and body temperature). Your vital
signs will be measured only once during this visit.
 A urine pregnancy test for females who may be able to become pregnant. The result of the
pregnancy test must show that you are not pregnant for you to continue participating in
this study.
 Ask about how you have been feeling and if you have had any medical procedures.
 Ask if you have recently been to an emergency room or have been hospitalized since your
last study visit.
These visits may take up to 1 hour or more.
Telephone Contacts 5a, 10a, 15a, and 20a [Year 1]
Telephone Contacts 25a, 30a, 35a, and 40a [Year 2]
Telephone Contacts:
The telephone contacts listed above are similar and apply to both treatment arms. At Week 8 of
each 12-week treatment cycle, your study doctor and/or study staff will contact you by telephone
to collect the following information:



Ask about any medications you are currently taking, including those you buy without a
prescription.
Ask if you have recently been to an emergency room or have been hospitalized since your
last study visit.
Ask about how you have been feeling and if you have had any medical procedures.
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Visit 41
End of Treatment or Early Withdrawal Visit:
This is the last visit of the final treatment cycle. Even if you do not complete the study, Visit 41
should be completed as the Early Withdrawal Visit. Your study doctor and/or study staff will:










Ask about any medications you are currently taking, including those that you buy without
a prescription.
Ask you to mark on a scale how active you feel your lupus disease is at the moment.
Measure your weight.
Measure your vital signs (blood pressure, pulse rate, and body temperature). Your vital
signs will be measured only once during this visit.
Collect blood and urine samples for laboratory values. Approximately 7 teaspoons of
blood will be needed. For females who may be able to become pregnant, this includes a
urine pregnancy test.
Collect additional blood (approximately 1 teaspoon) to determine the levels of possible
antibodies against epratuzumab in your blood.
Perform lupus assessments.
Provide you with questionnaires that will ask about your physical and emotional well
being, your social life and quality of life, your lupus symptoms and your level of fatigue.
Ask about how you have been feeling and if you have had any medical procedures.
Ask if you have recently been to an emergency room or have been hospitalized since your
last study visit.
This visit may take up to 2 or more hours. You may be asked to stay at the study doctor’s office
or clinic a little longer after all of the visit procedures are completed in order to be observed.
This is to ensure that you are well enough to leave the study doctor's office or clinic.
Visit 42
Safety Follow-up Visit:
If you complete the study or withdraw from this study early, you will complete the Safety
Follow-Up Visit. This will be the last visit of this study. This visit will occur either 4 weeks after
the End of Treatment Visit or 13 weeks after your last infusion if you complete an Early
Withdrawal Visit. Your study doctor and/or study staff will:



Ask about any medications you are currently taking, including those that you buy without
a prescription.
Measure your vital signs (blood pressure, pulse rate, and body temperature). Your vital
signs will be measured only once during this visit.
Collect blood and urine samples for laboratory values. Approximately 3 teaspoons of
blood will be needed. For females who may be able to become pregnant, this includes a
urine pregnancy test.
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


Collect additional blood (approximately 1 teaspoon) to determine the levels of possible
antibodies against epratuzumab in your blood.
Ask about how you have been feeling and if you have had any medical procedures.
Ask if you have recently been to an emergency room or have been hospitalized since your
last study visit.
This visit may take up to 1 hour or more. You may be asked to stay at the study doctor’s office
or clinic a little longer after all of the visit procedures are completed in order to be observed.
This is to ensure that you are well enough to leave the study doctor's office or clinic.
Blood for Laboratory Tests:
At some of the scheduled study visits, blood for laboratory tests will be taken as outlined above.
The amounts taken at each visit will be between 4 teaspoons (20 milliliters) and 8 teaspoons (40
milliliters). During the entire study a total of about 295 milliliters (about 1 ¼ cups) will be taken.
This total amount is about ⅔ amount of blood taken when a person donates blood.
Unscheduled Visits:
At any time during the study, you may be asked to return to your study doctor’s office or clinic
for an additional visit if you experience any side effects or if any test must be repeated (for
example, an abnormal laboratory test). At an Unscheduled Visit your study doctor and/or study
staff could possibly:





Ask about any medications you are currently taking, including those that you buy without
a prescription.
Measure your vital signs (blood pressure, pulse rate, and body temperature). Your vital
signs will be measured only once during this visit.
Collect blood and urine samples for laboratory values. At a maximum, approximately
7 teaspoons of blood will be needed. For females who may be able to become pregnant,
this includes a urine pregnancy test.
Ask about how you have been feeling and if you have had any medical procedures.
Ask if you have recently been to an emergency room or have been hospitalized since your
last study visit.
SUBJECT OR PARTICIPANT RESPONSIBILITIES
If you decide to participate in this study, it is important to keep all scheduled appointments and to
tell your study doctor about any medical problems you have, even if they are not related to your
lupus disease or your participation in this study.
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Please keep your study doctor informed of all medications that you take during this study, even if
it is medicine that you buy without a prescription (including vitamins and supplements).
Generally, you should continue taking your other medications as prescribed by your doctor. You
should not change your medications or the doses unless directed by your study doctor. There
may be some medications you take that are not allowed during the course of the study. Taking
medications that are not allowed could exclude you from participating in the study. Your study
doctor will determine the course of action if a disallowed medication is taken.
At some of the study visits, you will be asked to complete questionnaires and provide
information about your physical and emotional well being, the quality of your life, your relations
with friends and family, your lupus symptoms and your level of fatigue. These questionnaires
will need to be completed at the study doctor's office or clinic during your visit.
During the study your general health will be closely monitored.
If you are a blood donor, please do not give blood during the study (except for the samples taken
for the purpose of this study) or for six months after your final epratuzumab infusion because
epratuzumab may still be in your blood.
If your lupus gets worse while you are in the study, you and your study doctor will discuss
treatment options that are best for you. If this happens, it may be necessary for you to withdraw
from the study. Also, upon receiving new information, your study doctor might consider it to be
in your best interests to withdraw you from the study. He/she will explain the reasons and arrange
for your care to continue.
RISKS AND DISCOMFORTS
There are potential side effects and discomforts that you may experience associated with this
clinical research study. Please give this information careful thought and consideration. You
should talk to your study doctor if you have any questions.
Possible Risks and Discomforts from Being Treated with Epratuzumab:
Side effects and discomforts that could be expected in patients receiving epratuzumab include:
Blood and lymph-carrying system disorders:
Thrombocytopenia (low levels of platelets in the blood)
Heart disorders:
Palpitations (abnormal heartbeat) and tachycardia (increased heart rate)
Eye disorders:
Conjunctivitis (inflammation of the eye), ocular hyperaemia (eye redness), and blurred vision
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Stomach and bowel disorders:
Abdominal pain, nausea and vomiting
General disorders and infusion site conditions:
Chest pain, chills, and peripheral edema (swelling of tissues, often in lower limbs)
Immune system disorders:
Drug hypersensitivity (reaction to a drug) and anaphylactic reaction (acute and severe allergic
reaction)
Infections and infestations:
Limb abscess (abscess of the arm or leg), bronchitis (inflammation in parts of the lungs), cystitis
(infection of the bladder), influenza (the flu), onychomycosis (fungal infection of the nail), oral
candidiasis (thrush, yeast infection in the mouth), sinusitis (inflammation of the sinuses), and
vaginal mycosis (fungal infection of the vagina)
Investigations:
Weight increased (weight gain).
Metabolism and nutrition disorders:
Hypokalaemia (low potassium levels in the blood)
Muscle, skeleton and connective tissue disorders:
Arthralgia (joint pain), bursitis (inflammation of sacs of joint fluid), joint effusion (collection of
fluid in the joint), and tendonitis (inflammation of a tendon).
Nervous system disorders:
Dizziness, headache, hypoaesthesia (reduce sense of touch or sensation), migraine, and tremor
(quiver)
Psychiatric disorders:
Anxiety and insomnia (being unable to sleep)
Breathing and thorax disorders:
Dyspnea (shortness of breath) and pharyngolaryngeal pain (throat pain)
Skin and subcutaneous (under the skin) tissue disorders:
Ecchymosis (bruise), hyperhidrosis (abnormal sweating), pruritus (itching) and urticaria (hives)
Blood vessel disorders:
Flushing and hypertension (high blood pressure)
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Your body may develop its own antibodies against epratuzumab. Your blood will be tested
during the study for formation of antibodies against epratuzumab, called human anti-human
antibodies (HAHA). Low levels of antibodies have occurred in a few subjects, but it is possible
that these antibodies could interfere with certain laboratory tests or make you ineligible to receive
other antibody products. For these reasons, you must inform physicians and other medical
professionals in the future that you participated in this study.
Although there is no known impact on how epratuzumab affects the way your immune system
normally responds, additional precautions have been put into place for this study. If you have
received a live vaccine within the last 8 weeks or are planning to be vaccinated with a live
vaccine during this study, you will not be suitable to take part in this study. A live vaccine is a
vaccine with active microbes (virus or bacteria), meant to create a response in the body to fight
that particular microbe in the person who receives the vaccine, such as the measles–mumpsrubella vaccine or the oral polio vaccine.
Because epratuzumab acts on certain white blood cells, there is a potential risk of having either a
new infection or reactivating an old infection. Vaccination with a live vaccine of anyone living in
your household may present an increased risk of infection to you. If vaccinations with any live
vaccines have recently been administered or are recommended for yourself or household contacts
during the course of the study, please consult your study doctor.
Patients with lupus are potentially at increased risk for developing infections because in lupus
patients the immune system doesn't work properly. Additionally, due to this disruption of the
immune system, there is a possible risk for the development of malignancies (cancer) such as
non-Hodgkin’s Lymphoma (types of blood cancers). The increased risks of infection and
malignancy in lupus patients may also be higher when patients are taking medications that
suppress the immune system. Epratuzumab may increase these risks due to its effects on the
immune system.
Possible Risks and Discomforts from the Infusion:
All drugs have a potential risk of an allergic reaction, which, if not treated promptly, could
become life-threatening. Some subjects had allergic-type reactions when receiving epratuzumab
infusions, including nausea, somnolence (sleepiness), dizziness, headache, dyspnea (shortness of
breath), flushing, pyrexia (fever), asthenia (weakness), chest discomfort, and arthralgia (joint
pain).
Your study doctor and study staff at the hospital or medical treatment center are trained to handle
medical emergencies and will carefully monitor your condition during infusions. Treatment will
be provided as determined by the study doctor. If you suffer a severe allergic reaction, you will
not receive further study drug, and it is possible that you should not receive other antibody
products in the future.
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Other Risks
In this study, it is recommended that acetaminophen (a pain reliever) and diphenhydramine
(given to prevent and/or treat allergic reactions) or an alternate antihistamine chosen by your
study doctor are administered to you 30 to 60 minutes prior to receiving your infusion in order to
try to minimize possible reactions to the infusion. There are risks associated with taking both
acetaminophen and diphenhydramine or another antihistamine. Acetaminophen can cause liver
damage if overdosed or used regularly over a long period of time. Rarely, allergic reactions can
occur with acetaminophen use. Diphenhydramine (antihistamine) can cause sleepiness and
disturbed coordination. Other side effects could occur with the administration of these two
medications. For a complete listing of such events you are advised to read the package inserts for
each drug and discuss any concerns with your study doctor.
During this study, epratuzumab is given to you by intravenous (into the vein) infusion. At several
visits, blood samples will also be taken for analysis. You might experience discomfort, swelling,
bruising, infection or the formation of a blood clot at skin puncture sites where the infusion is
given or blood samples are taken. Possible side effects from blood drawing include localized
pain, bleeding, bruising or infection at the site where blood samples are drawn. Some patients
may feel dizzy from these procedures. If you know that you are prone to fainting, please tell the
study doctor or study staff before the blood samples are to be taken.
There may be other risks which are currently unexpected.
PREGNANCY
The effects of the study drug on the male and female reproductive system (i.e. sperm and egg
cell) or an unborn child are unknown and may be harmful. Because the safety of epratuzumab
during pregnancy and breast-feeding is unknown, women who are pregnant or breast-feeding
may not participate in this trial. It is important for women participating in the study to avoid
becoming pregnant during the course of the study and for 12 weeks (or 3 months) after the last
dose of study drug. Women of child bearing potential should use an acceptable method of birth
control to avoid pregnancy. Men participating in the study should make sure they or their female
partner use suitable birth control during the study and for 12 weeks (or 3 months) after the last
dose of study drug.
Acceptable forms of birth control include oral contraceptives ("the pill"), double-barrier methods
(i.e. two different methods of birth control at the same time), and the single-barrier methods of
diaphragm with additional spermicide or condom with additional spermicide. Also acceptable for
women is surgical sterilization (removal of the uterus or ovaries or tubal ligation ["tied tubes"])
or postmenopausal for at least 2 years prior to visit 1 of this study, meaning 24 consecutive
months without having a period. If you are taking oral contraception, this must be stable for at
least 1 full month prior to entry of SL0012 and should remain stable during the study.
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Should a pregnancy occur, notify your study doctor immediately and seek obstetrical (pertaining
to the treatment of women in childbirth) care. Women who become pregnant will be withdrawn
from the study. Both for pregnant female study participants and pregnant partners of male study
participants, the Sponsor will follow the pregnancy until the birth of the baby and will request
access to the mother’s pregnancy related medical records as well as the infant’s hospital/clinic
records.
NEW FINDINGS
During the course of this research study, new findings or information may become available
about epratuzumab. If this happens, your study doctor will tell you about it and discuss with you
whether you want to continue in the study. If you decide to continue in the study you will be
asked to sign an updated Informed Consent Form. If you decide to withdraw, your study doctor
will make arrangements for your care to continue. You should also be aware that UCB, Inc. could
stop the study at any time. In this situation your study doctor will discuss alternative treatment
with you.
BENEFITS
Participation in this study may be beneficial in treating your condition and may improve your
lupus symptoms. It is also possible that your condition will not improve. While you may not have
a direct health benefit from participating in this study, the information gathered during this study
will help researchers to find out if epratuzumab will help other people with lupus.
COSTS
There will be no charge to you for participating in this study.
During this study, epratuzumab (study drug) will be provided free of charge by UCB, Inc. There
will be no charge to you or your insurance company for epratuzumab. The cost of any other
medications (including your lupus medications prescribed by your doctor) that you may use
during the study will be billed to you or your insurance plan.
Neither you nor your insurance company will be charged for procedures and study visits
performed for the purpose of this study.
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.
You might have unexpected expenses from being in this study. Ask your study doctor to discuss
the costs that will or will not be covered by the sponsor. This discussion should include who will
pay the costs of treating possible side effects.
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PAYMENT FOR PARTICIPATION
You will be paid $30 for each completed visit. Parking will be provided at no cost.
ALTERNATIVE TREATMENT
As lupus is a chronic (long lasting) disease involving different symptoms and organs with no
known cure, treatment is restricted to dealing with the symptoms; essentially this involves
preventing flares (onset of lupus symptoms) and reducing their intensity and length of time they
occur. There are several ways of preventing and dealing with flares, including drugs, alternative
medicine (e.g. acupuncture) and lifestyle changes (e.g. weight loss and sun protection). Mild
lupus can sometimes be safely left untreated.
There are other medications that are used to treat the symptoms of lupus. These medications can
be used to prevent or reduce the number of flares, or for severe symptoms or other organdamaging complications. These medications include non-steroidal anti-inflammatory drugs
(NSAIDs, e.g. ibuprofen), disease-modifying antirheumatic drugs (DMARDs), antimalarials (e.g.
chloroquine and hydroxychloroquine), immunosuppressants (e.g. methotrexate and azathioprine),
treatment with a monoclonal antibody (e.g. belimumab) or other types of medications such as
cyclophosphamide.
In more severe cases, medications that manage the immune system (primarily corticosteroids and
immunosuppressants or another antibody, which was approved by the FDA) are used to control
the disease and prevent flares. Patients who require steroids may develop serious side effects,
especially if these are given at high doses or over a long period of time.
All of these alternative medications can cause side effects or allergic reactions. Your study doctor
will discuss the potential side effects, benefits and risks of alternative treatments with you before
you decide to participate in this study or if you choose to withdraw.
AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH
PURPOSES
Federal regulations give you certain rights related to your health information. These include the
right to know who will be able to get the 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. Records of your participation in this study will be held confidential so
far as permitted by law.
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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:






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
HIV / AIDS
Hepatitis infection
Sexually transmitted diseases
Other reportable infectious diseases
Physical exams
Laboratory, x-ray, and other test results
Diaries and Questionnaires
The diagnosis and treatment of a mental health condition
Records about any study drug you received
If you receive services in University Hospital as part of this trial, this informed consent document
will be placed in and made part of your permanent medical record at these facilities.
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.
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:




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,
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


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.
The 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.
Information from your medical record can be reviewed by foreign regulatory agencies similar to
the U.S. Food and Drug Administration. This is outlined in the International Conference on
Harmonization – Good Clinical Practice Guidelines. These agencies may include the European
Commission and the Japanese Ministry of Health and Welfare. 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. The UAB IRB staff member will ensure that the medical
record is not removed and that identifiable information is not 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 may be shared with the UAB or UAB Health System affiliates billing services. This
would be done so that the sponsor or your insurance can be appropriately billed for certain study
activities.
“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.”
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.
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May I review or copy the information obtained from me or created about me?
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 which might identify you will
be gathered after that date. Information that has already been gathered may still be used and
given to others. This would be done if it were necessary for the research to be reliable.
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.
COMPENSATION FOR INJURY
Sponsor’s Statement
In the event of any physical injury resulting directly from taking the study drug or any properly
performed procedure during your participation in the study, UCB, Inc. agrees to pay, according to
insurance subscribed to by UCB, Inc. only those medical expenses necessary to treat such injury
as follows:
 to the extent that the study subject is not otherwise reimbursed by medical insurance
 and provided that the study subject has followed the directions of the study doctor.
No other compensation will be routinely available. Any injury believed to be caused by the study
drug must be reported promptly to the study doctor.
UAB’s Statement
UAB has made no provision for monetary compensation in the event of injury resulting from the
research. In the event of such injury, treatment is provided, but is not provided free of charge.
You or your medical insurance will be billed for the cost of such treatment.
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VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is voluntary. If you decide not to continue your treatment of
epratuzumab in this study, you may choose to withdraw at anytime without penalty or loss of
benefits to which you are otherwise entitled.
In addition, your participation may be ended at any time by your study doctor, a regulatory
authority, UCB, Inc. or designee without your consent for any of the following reasons:



if it is in your best interest;
you do not consent to continue in the study after being told of changes in the research that
may affect you;
or for any other reason.
If you choose to withdraw your consent or are withdrawn by your study doctor you will be asked
to cooperate by having whatever laboratory tests and examinations necessary to complete your
participation in the study.
If you withdraw from the study, you have the right to have all previously retained samples
destroyed and not used for future analysis. To have all previously retained samples destroyed,
you must notify your study doctor in writing.
SOURCE OF FUNDING FOR THE STUDY
The study doctor W. Winn Chatham, M.D. and institution (UAB) are being paid by UCB, Inc. to
conduct this research.
QUESTIONS
If you have any questions, concerns or complaints about this study or your participation in this
study, or if at any time you feel you have experienced a research-related injury or a reaction to the
study medication, contact:
Dr. W. Winn Chatham at 866-876-2247
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.
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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 1-800-8228816. If calling the toll-free 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.
Do not sign this consent form unless you have had a chance to ask questions and have received
satisfactory answers to all of your questions.
If you agree to participate in this study, you will receive a signed and dated copy of this consent
form for your records.
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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 participate in this research study.
I authorize the use and disclosure of my health information to the parties listed in the authorization
section of this consent for the purposes described above.
By signing this consent form I have not waived any of the legal rights that I otherwise would have
as a subject in a research study.
________________________________________
Subject Name
CONSENT SIGNATURE:
Signature of Subject
Date
Signature of Person Conducting Informed
Consent Discussion
Date
Witness
Date
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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
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