Sandwell & West Birmingham Hospitals
NHS Trust
PERFORMANCE IN DELIVERING CLINICAL RESEARCH
Research
Ethics
Committee
Reference
Number
13/EE/0339
14/EM/1059
14/NW/0130
13/NW/0858
14/EE/0102
14/WS/0004
14/EE/0059
Name of Trial
A randomized controlled trial of
rivaroxaban for the prevention of
major cardiovascular events in
patients with coronary or
peripheral artery disease
(COMPASS - Cardiovascular
OutcoMes for People using
Anticoagulation StrategieS)
047 FIT - C-935788-047 A Phase
3, Multi-Center, Randomized,
Double-Blind, Placebo-Controlled,
Study of Fostamatinib Disodium in
the Treatment of
Persistent/Chronic Immune
Thrombocytopenic Purpura
RESPONSE: A randomised,
double blind, multi-center,
placebo-controlled study to
evaluate the efficacy, safety, and
tolerability of NT100 in pregnant
women with a history of
unexplained recurrent pregnancy
loss (RPL)
Assessment of an Education and
Guidance programme for Eliquis
Adherence in Non-Valvular Atrial
Fibrillation (AEGEAN)
ENSURE in AF (atrial fibrillation)
study. A prospective, randomized,
openlabel, blinded endpoint
evaluation (PROBE) parallel group
study comparing edoxaban
(DU176b) with enoxaparin/warfarin
followed by warfarin alone in
subjects undergoing planned
electrical cardioversion of
nonvalvular atrial fibrillation
Open-Label Extension Study of
EFC12492, R727-CL-1112,
EFC12732, & LTS11717
Studies to Assess the Long-Term
Safety and Efficacy of Alirocumab
in Patients with Heterozygous
Familial Hypercholesterolemia
ODYSSEY OLE
Post-Market Multicentric
Evaluation of the AQUESYS XEN
Implant in Moderate Primary Open
Angle Glaucoma Subjects. MS001 Study
Q1 (2015-2016)
Target
Recruitment
Date
Agreed to
Recruit
Target
Number
Trial
Status
Target
Met
Within
Agreed
Time
50
30/09/2015
OPEN
N/A
3
01/09/2015
OPEN
N/A
7
31/03/2015
CLOSED AT
SITE
NO
12
31/03/2015
CLOSED In Follow-up
NO
9
01/12/2015
OPEN
YES
4
31/12/2014
CLOSED
YES
10
02/02/2015
CLOSED In Follow-up
NO
Page 1 of 6
14/EE/0102
14/SC/0032
SPIRE 2: B1481038 Phase 3
multi-center, double-blind,
randomized, Placebo-controlled,
parallel group evaluation of the
Efficacy, safety, and tolerability of
pf-04950615, in reducing the
Occurrence of major
cardiovascular events in high risk
Subjects
Phase 3, Multi-Centre, DoubleBlind, Randomised, Placebocontrolled, Parallel Group
Evaluation of the Efficacy, Safety
and Tolerability of PF-04950615,
in reducing the occurrence of
major cardiovascular events in
high risk subjects. SPIRE 1.
2
01/10/2015
OPEN
N/A
5
31/10/2014
OPEN
N/A
14/SC/0100
Ocriplasmin for Vitreomacular
Traction/Symptomatic
Vitreomacular Adhesion
6
31/03/2015
CLOSED
YES
13/LO/1320
A Phase III, Multi-National, MultiCenter, Randomized, Masked,
Controlled, Safety and Efficacy
Study of a Fluocinolone Acetonide
Intravitreal (FAI) Insert in Subjects
with Chronic Non-Infectious Uveitis
Affecting the Posterior Segment of
the Eye (pSivida)
2
31/03/2015
CLOSED In Follow-up
YES
2
30/09/2015
OPEN
YES
2
01/02/2015
CLOSED In Follow-up
YES
10
28/04/2015
CLOSED In Follow-up
NO
2
15/05/2014
CLOSED In Follow-up
YES
5
31/08/2015
OPEN
N/A
13/NE/0269
13/EE/0241
14/WM/003
13/SC/0423
09/H0301/5
PR-30-5011-C - A Phase 3
Randomized Double-Blind Trial of
Maintenance with Niraparib Versus
Placebo in Patients with Platinum
Sensitive Ovarian Cancer
SIGNATURE. Secukinumab In
patients with moderate to severe
active, chronic plaque psoriasis
who have failed on TNFα
antaGoNists: A clinical Trial
EvalUating Treatment REsults
HYDRUS V: A Prospective,
Multicentre, Randomised,
Comparison of the Hydrus™ to
the iStent™ for Lowering
Intraocular Pressure in Primary
Open Angle Glaucoma
Spock - A dose finding study to
assess the safety and efficacy of
K-877 in patients with statincontrolled LDL-C but abnormal
lipid levels
THE CONTINUUM TRIAL. A
Phase 3, Multi-centre,
Randomised, Double-blind,
Placebo-controlled, Parallel-group
study of the Efficacy and Safety of
Lenalidomide (Revlimid®) as
Maintenance Therapy for Patients
with B-Cell Chronic Lymphocytic
Leukaemia following Second-line
Therapy
Page 2 of 6
12/WM/0341
13/LO/1264
13/EM/0254
13/WM/0208
13/NE/0201
11/LO/1658
12/LO/0984
FOURIER. A Double-blind,
Randomized, Placebo-controlled,
Multicenter Study Assessing the
Impact of Additional LDLCholesterol Reduction on Major
Cardiovascular Events When AMG
145 is Used in Combination With
Statin Therapy In Patients with
Clinically Evident Cardiovascular
Disease
SOLO2. A Phase III, Randomised,
Double Blind, Placebo Controlled,
Multicentre Study of Olaparib
Maintenance Monotherapy in
Platinum Sensitive Relapsed
BRCA Mutated Ovarian Cancer
Patients who are in Complete or
Partial Response Following
Platinum based Chemotherapy
PROMETHEUS . A 12-month,
randomized, double-masked,
sham-controlled, multicenter study
to evaluate the efficacy and safety
of 0.5mg ranibizumab intravitreal
injections in patients with visual
impairment due to vascular
endothelial growth factor (VEGF)
driven macular edema (ME)
A Randomised, Double-blind,
Placebo-controlled, Multiple Dose,
Parallel, Multiple Dose-Level Study
to Evaluate the Safety, Tolerability,
Pharmacokinetics,
Pharmacodynamics and Clinical
Effect of AMG 557 in Systemic
Lupus Erythematosus (SLE)
Subjects with Active Lupus
Arthritis
SOLO 1. A Phase III,
Randomised, Double Blind,
Placebo Controlled, Multicentre
Study of Olaparib Maintenance
Monotherapy in Patients with
BRCA Mutated Advanced (FIGO
Stage III-IV) Ovarian Cancer
following First Line Patinum Based
Chemotherapy.
LUMIGAN 056. A Multicenter,
Double-masked, Randomized,
Active-controlled, Parallel Study of
the Safety and Efficacy of Oncedaily Bimatoprost Preservativefree Ophthalmic Solution
Compared to Twice-daily Timolol
Ophthalmic Solution in Paediatric
Patients With Glaucoma
A Randomised, Open-Label,
Phase 2 Study of the IDO Inhibitor
INCB024360 (I) Versus Tamoxifen
(C) for Subjects with Biochemicalrecurrent-only Epithelial ovarian
cancer, Primary Peritoneal
Carcinoma or Fallopian Tube
Cancer (P) Following Complete
Remission with First-line
Chemotherapy.
30
31/03/2015
CLOSED In Follow-up
YES
6
08/01/2015
CLOSED In Follow-up
NO
2
06/08/2014
CLOSED In Follow-up
YES
3
30/05/2015
CLOSED
NO
4
08/01/2015
CLOSED
NO
2
01/09/2014
CLOSED In Follow-up
NO
4
01/08/2014
CLOSED
NO
Page 3 of 6
13/NW/0363
13/LO/0528
12/WS/0300
13/WM/0046
12/WS/0184
13/LO/0049
11/EM/0074
13/EM/0017
OSLER 2: A Multicenter Openlabel Extension (OLE) Study to
Assess the Long-term Safety and
Efficacy of AMG 145
PIONEER-AF. An Open-label,
Randomized, Controlled,
Multicenter Study ExplorIng Two
Treatment Strategies of
Rivaroxaban and a Dose-Adjusted
Oral Vitamin K Antagonist
Treatment Strategy in Subjects
With Atrial Fibrillation Who
Undergo Percutaneous Coronary
Intervention
ODYSSEY OUTCOMES: A
Randomized, Double-Blind,
Placebo-Controlled, Parallel-Group
Study to Evaluate the Effect of
SAR236553/REGN727 on the
Occurrence of Cardiovascular
Events in Patients Who Have
Recently Experienced an Acute
Coronary Syndrome
HYDRUS III. A Prospective,
Multicentre, Randomised
Comparison of the Hydrustm
Aqueous Implant to the iStent for
lowering Intraocular Pressure in
Glaucoma Subjects Undergoing
Cataract Surgery
Multi-Center, Open-Label,
Randomized Study of Anti-CCR4
Monoclonal Antibody KW-0761
versus Investigator’s Choice in
Subjects with Previously Treated
Adult T-cell Leukemia-Lymphoma
(ATL)
REPARO. An 8-week phase I/II,
multicenter, randomized, doublemasked, vehicle controlled parallel
group study with a 48 or 56 week
follow-up period to evaluate the
safety and efficacy of two doses
(10 µg/ml and 20 µg/ml) of
recombinant human nerve growth
factor eye drops solution versus
vehicle in patients with Stage 2
and 3 of Neurotrophic Keratitis
LUMIGAN 054. A 2-year,
multicenter, double-masked,
randomized, parallel study of the
safety of LUMIGAN® 0.1 mg/mL
compared with LUMIGAN® 0.3
mg/mL in patients with glaucoma
or ocular hypertension
A 3-Month, Multi-Center, DoubleMasked Safety and Efficacy Study
of Travoprost Ophthalmic Solution,
0.004% Compared to Timolol
(0.5% or 0.25%) in Pediatric
Glaucoma Patients
2
12/05/2014
CLOSED In Follow-up
NO
8
31/08/2015
OPEN
YES
20
31/12/2015
OPEN
N/A
18
28/04/2015
CLOSED In Follow-up
NO
3
01/05/2015
CLOSED In Follow-up
YES
2
01/06/2015
CLOSED In Follow-up
NO
12
31/10/2014
CLOSED In Follow-up
NO
2
01/08/2013
CLOSED In Follow-up
YES
Page 4 of 6
12/EE/0533
12/EE/0532
12/NW/0670
12/WM/0341
12/LO/1650
12/WM/0348
12/WM/0290
12/LO/0482
ODYSSEY Options II. A
Randomized, Double-Blind Study
of the Efficacy and Safety of
REGN727 Added-on to
Rosuvastatin versus Ezetimibe
Added-on to Rosuvastatin versus
Rosuvastatin Dose Increase in
Patients Who are Not Controlled
on Rosuvastatin (Regeneron
R727-CL-1118)
ODYSSEY OPTIONS I. A
Randomised, Double-Blind Study
of the Efficacy and Safety of
REGN727 Added-on to Atovastatin
versus Ezetimibe Added-on to
Atorvastatin versus Atorvastatin
Dose Increase versus Switch to
Rosuvastatin in Patients Who are
Not Controlled on Atorvastatin
(Regeneron R727-CL-1110)
A Randomized, Double-blind,
Placebo-controlled Study to
Evaluate the Safety, Tolerability,
and Efficacy of AMG 181 in
Subjects with Moderate to Severe
Crohn’s Disease (Protocol
20110232) TRAFFIC CD
FOURIER. A Double-blind,
Randomized, Placebo-controlled,
Multicenter Study Assessing the
Impact of Additional LDLCholesterol Reduction on Major
Cardiovascular Events When AMG
145 is Used in Combination With
Statin Therapy In Patients with
Clinically Evident Cardiovascular
Disease
EYEGUARD-B: A randomized,
double-masked, placebocontrolled study of the efficacy of
gevokizumab in the treatment of
patients with Behçet’s Disease
uveitis.
The RELIEF Study. Polycythemia
Vera Symptom Study Evaluating
Ruxolitinib Versus Hydroxyurea in
a Randomized, Multicenter,
Double-Blind, Double-Dummy,
Phase 3 Efficacy and Safety Study
of Patient Reported Outcomes
A double, randomised, multicentre
study to evaluate safety and
efficacy of AMG 145, compared
with ezetimibe, in
hypercholesterolemic subjects
unable to tolerate an effective
dose of a HMG-CoA reductase
inhibitor 20110116 (GAUSS 2)
PERUSE. A multicenter, openlabel, single-arm study of
pertuzumab in combination with
trastuzumab and a taxane in first
line treatment of patients with
HER2-positive advanced
(metastatic or locally recurrent)
breast cancer.
3
01/08/2013
CLOSED In Follow-up
NO
3
09/08/2013
CLOSED
NO
5
30/11/2014
CLOSED In Follow-up
NO
30
31/03/2015
CLOSED In Follow-up
YES
2
01/09/2014
CLOSED
NO
1
15.11.2013
CLOSED In Follow-up
YES
6
23/07/2013
CLOSED In Follow-up
NO
4
30/11/2013
CLOSED In Follow-up
NO
Page 5 of 6
12/NW/0014
10/H0718/93
11/LO/1619
FOCUS FH. A Phase 3,
Randomized, Double-Blind,
Placebo-Controlled, Parallel-Group
Study to Assess the Safety and
Efficacy of Two Different
Regimens of Mipomersen in
Patients with Familial
Hypercholesterolemia and
Inadequately Controlled LowDensity-Lipoprotein Cholesterol
(MIP038)
ALLOS PDX-017. A Multi-center,
Randomized, Phase 3 Study of
Sequential Pralatrexate Versus
Observation in Patients with
Previously Undiagnosed
Peripheral T-cell Lymphoma Who
Have Achieved an Objective
Response Following Initial
Treatment with CHOP-based
Chemotherapy
ALTERNATIVE. Comparing safety
& efficacy of
AI/lapatanib/trastuzumab in
HR+HER2 MBC
6
22/11/2013
CLOSED In Follow-up
NO
7
30/08/2013
CLOSED In Follow-up
NO
5
02/01/2015
CLOSED
NO
Page 6 of 6