Sandwell & West Birmingham Hospitals
NHS Trust
PERFORMANCE IN DELIVERING CLINICAL RESEARCH
Research
Ethics
Committee
Reference
Number
14/EM/1059
14/NW/0130
13/NW/0858
14/EE/0102
14/WS/0004
14/EE/0059
14/EE/0102
14/SC/0032
Name of Trial
Q4 (2014-2015)
Target
Recruitment
Date
Agreed to
Recruit
Target
Number
Trial
Status
Target
Met
Within
Agreed
Time
3
15/06/2015
OPEN
N/A
7
31/03/2015
CLOSED
AT SITE
NO
12
31/03/2015
CLOSED
- In
Follow-up
NO
9
01/05/2015
OPEN
N/A
4
31/12/2014
CLOSED
NO
10
02/02/2015
CLOSED
- In
Follow-up
NO
2
01/10/2015
OPEN
N/A
5
31/10/2014
OPEN
N/A
047 FIT - C-935788-047 A Phase 3,
Multi-Center, Randomized, DoubleBlind, Placebo-Controlled, Study of
Fostamatinib Disodium in the
Treatment of Persistent/Chronic
Immune Thrombocytopenic Purpura
RESPONSE: A randomised, double
blind, multi-center, placebocontrolled 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. MS-001 Study
SPIRE 2: B1481038 Phase 3 multicenter, 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.
Page 1 of 5
14/SC/0100
13/LO/1320
13/NE/0269
13/EE/0241
14/WM/003
13/SC/0423
09/H0301/5
13/LO/1264
13/EM/0254
Ocriplasmin for Vitreomacular
Traction/Symptomatic Vitreomacular
Adhesion
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)
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 K877 in patients with statin-controlled
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
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, shamcontrolled, 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)
Page 2 of 5
6
31/03/2015
CLOSED
- In
Follow-up
YES
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
OPEN
N/A
2
15/05/2014
CLOSED
- In
Follow-up
YES
5
31/08/2015
OPEN
N/A
6
08/01/2015
CLOSED
- In
Follow-up
NO
2
06/08/2014
CLOSED
- In
Follow-up
YES
13/WM/0208
13/NE/0201
11/LO/1658
12/LO/0984
13/NW/0363
13/LO/0528
12/WS/0300
13/WM/0046
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 Preservative-free
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.
OSLER 2: A Multicenter Open-label
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
Page 3 of 5
3
30/05/2015
OPEN
N/A
4
08/01/2015
CLOSED
NO
2
01/09/2014
CLOSED
NO
4
01/08/2014
CLOSED
- In
Follow-up
0
2
12/05/2014
CLOSED
- In
Follow-up
NO
8
01/03/2015
OPEN
YES
20
31/122015
OPEN
N/A
18
28/04/2015
OPEN
N/A
12/WS/0184
13/LO/0049
11/EM/0074
13/EM/0017
12/EE/0533
12/EE/0532
12/NW/0670
12/WM/0341
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
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 R727CL-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-CL1110)
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
Page 4 of 5
3
01/05/2015
OPEN
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
3
01/08/2013
CLOSED
- In
Follow-up
NO
3
09/08/2013
CLOSED
NO
5
30/11/2014
CLOSED
- In
Follow-up
NO
20
31/03/2015
CLOSED
- In
Follow-up
YES
12/LO/1650
12/WM/0348
12/WM/0290
12/LO/0482
12/NW/0014
10/H0718/93
11/LO/1619
EYEGUARD-B: A randomized,
double-masked, placebo-controlled
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, DoubleBlind, 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, open-label,
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.
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
Page 5 of 5
2
01/09/2014
OPEN
N/A
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
6
22/11/2013
CLOSED
- In
Follow-up
NO
7
30/08/2013
CLOSED
- In
Follow-up
NO
5
02/01/2015
CLOSED
NO