Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 October September 2013

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Hortense Audrey Chase
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1 Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 October September 2013 Research Ethics Committee reference number Name of Trial 1 12/NW/0321 A Long-Term Study for Extended BMN 701Treatment of Patients with Pompe Disease who have Completed BMN 701 Studies 2 11/EE/0415 A single arm, open label, phase II, multicentre study, to assess the safety of vismodegib (GDC0449) in patients with locally advanced or metastatic basal cell carcinoma (BCC) 3 12/WM/0193 A Randomized, Double blind, Placebo controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome 4 12/EE/0089 A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Efficacy and Safety of LY to Etanercept and Placebo in Patients with Moderate to Severe Plaque Psoriasis 5 11/YH/0442 Enhanced Control of Hypertension and Thrombolysis Stroke Trial 6 12/YH/0151 HERO: Hydroxychloroquine Effectiveness in Reducing Symptoms of hand OA, a randomised, double blind, placebo controlled trial 7 12/EM/0279 A Phase IIb, Double Blind, Randomized, Placebo Controlled, Double Dummy, Dose Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS in Subjects with Moderate to Severe Crohn's Disease 8 12/EE/0176 Randomised phase IV placebo controlled comparative study to evaluate the efficacy and safety of Date of receipt of valid research application Date of first patient first visit Reason for not achieving benchmark 29/08/12 11/12/12 Staff 24/08/12 13/12/12 Rare disease 23/08/12 21/06/13 No patients consented 01/10/12 15/04/13 Staff 03/09/12 20/01/13 Sponsor 06/07/12 11/03/13 Contracting s 07/09/12 N/A Closed by sponsor 30/07/12 15/02/13 Sponsor

2 tapering methotrexate (MTX) dosage vs. Maintaining the dosage in patients with severe active rheumatoid arthritis 9 12/NW/0249 A Phase III Trial of Prophylactic Irradiation of Tracts in Patients with Malignant Pleural Mesolthelioma Following Invasive Chest Wall Intervention /NM/0208 Randomised controlled trial of oral supplements in weight losing colorectal cancer patients /NE/0161 A phase 4 prospective exploratory muscle biopsy, biomarker, and imaging assessment study in patients with late-onset Pompe disease treated with alglocosidase alfa 12 08/H1211/142 A randomised, controlled crossover study of deep brain stimulation for severe, intractable Gilles de la Tourette Syndrome 13 11/NE/0038 A Randomized, Double Blind, Placebo Controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (=16 To 80 Years Old) With Partial Onset Seizures 14 12/NW/0459 Study to Investigate the Safety, Tolerability, Mechanism of Action and Exploratory Clinical Efficacy of Repeat DoseHF1020 in Patients with Moderate to Severe Psoriasis 15 11/NE/0039 An Open-Label, Multicenter, Followup Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older with Partial Onset Seizures 16 12/YH/0249 An Open Label, Multicenter, Follow Up Study to Evaluate the Long Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older with Epilepsy 17 12/ES/0074 A multicentre, extension study of subcutaneous secukinumab in prefilled syringes to demonstrate long term efficacy, safety and tolerability 26/09/12 02/07/13 No patients 17/10/12 18/02/13 No patients 31/07/12 N/A No patients 06/11/12 04/02/13 No patients 11/10/12 30/01/13 Sponsor 01/06/12 30/01/13 Sponsor 25/10/12 N/A Sponsor 04/10/12 N/A Sponsor 03/10/12 16/01/13 No patients

3 up to 2 years in subjects with moderate to severe chronic plaque type psoriasis 18 11/NE/0301 ANDANTE ii 17/09/12 N/A Closed by sponsor 19 12/WM/0224 QUeen Elizabeth physiotherapy post lumbar discectomy Study: pilot work to improve service delivery and inform the development of a randomised controlled trial QUEST 20 12/NW/0785 A multicentre, randomised, double blind, placebo controlled, dose ranging study to evaluate the safety and efficacy of GSK in patients with chronic plaque psoriasis 21 12/LO/1297 Double Blind, Randomized, Placebo Controlled, 8 Week Study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis /ES/0023 Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis? A multicentre randomized placebo controlled trial 23 10/H0405/29 The Fistula-In-Ano trial comparing Surgisis anal fistula plug versus surgeon's preference for transsphincteric fistula-in-ano 24 12/EE/0274 Tranexamic Acid for the treatment of significant traumatic brain injury: an international, randomised, double blind, placebo controlled trial /NW/0502 A Cerebrospinal Fluid Collection Study in Paediatric and Adult Patients with Hunter Syndrome 26 12/NW/0824 Effects of intragastric glucose and fructose on gastric emptying and concentrations of blood glucose, fructose, insulin and glucagon-like peptide /YH/0504 Assessment of the efficacy and safety of a new wound dressing in the local treatment of diabetic foot ulcers: A Prospective, randomised, controlled, 11/09/12 16/01/13 Contracting s 14/11/12 09/04/13 Sponsor 07/01/13 N/A No patients 23/10/12 08/05/13 Permissions ed 27/09/12 N/A Staff 28/01/13 07/05/13 Permissions ed 18/11/12 19/04/13 Staff 22/01/13 17/04/13 Permissions ed 18/12/12 N/A No patients

4 double-blind, European multi-centre clinical trial /H0906/140 A randomised, double-blind, parallelgroup, placebo-controlled phase III study to evaluate the efficacy and safety of desmoteplase in subject s with acute ischemic stroke. Study 12649A DIAS-4 26 Aug /LO/0105 Open label,single arm,phase IV, multi centre trial to explore the immunogenicity of the liquid formulation of Saizen? in subjects with growth hormone deficiency (GHD) of adult onset 30 12/EE/0533 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 31 11/NW/0548 Phase III RIALTO: A Randomised Investigation of Alternative Ofatumumabcontaining regimens in less fit patients with CLL 32 12/EE/0492 A Multicenter, Randomized, Placebo- Controlled Study of SBC-102 in Patients with Lysosomal Acid Lipase Deficiency 33 13/LO/0157 Study MAG104615, A Proof of Concept Study for GSK versus placebo in Stroke Patients 34 13/NW/0362 Effect of Lateral WEDGE insoles on Osteoarthritis knee pain and joint loading. The WEDGE study 35 13/SC/0092 A Multi Center, Randomized, Double Blind, Parallel Group, Placebo Controlled Variable Treatment Duration Study evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients with Secondary Progressive Multiple Sclerosis 36 13/LO/0383 A Randomized, Double Blind, Double Dummy, ActiveControlled Study to Evaluate the Efficacy and Safety of REGN727/SAR in Patients with Primary Hypercholesterolemia Who are Intolerant to Statins 21/03/13 N/A Other 27/03/13 01/07/13 Staff 31/01/13 30/06/13 No patients 20/06/12 N/A Permissions ed 01/03/13 N/A No patients 15/05/13 N/A No patients 02/05/13 Date unavailable Staff 15/05/13 N/A Sponsor 31/05/13 N/A No patients

5 37 12/SS/0059 A Randomised Controlled Clinical Trial of Adjunctive Mechanical Thrombectomy Compared with Intravenous Thrombolysis in Patients with Acute Ischaemic Stroke due to an Occluded Major Intracranial Vessel 38 13/EM/0052 SPIRiT Serum Phosphate Intervention in Renal Replacement Therapy 39 12/EE/0532 A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atorvastatin versus Ezetimibe Added-on to Atorvastatin versus 40 12/WS/0145 A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta- 1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis 41 12/NW/0600 Unravelling the underlying mechanisms of dysphagia in Stroke and neurodegenerative disease models with neuroimaging /EM/0369 Tranexamic acid for IntraCerebral Haemorrhage TICH /NW/0007 Real time electrophysiological model of ongoing pain for neurofeedback applications 44 13/NW/0130 Delivering a Mouth Hygiene Complex Intervention for Stroke Unit Care: A Pilot Study 45 13/EM/0095 A Phase III Randomised, Multicentre Study of Subcutaneous Secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks & to assess the long term efficacy up to 5 years in patients with Active Psoriatic Arthritis /H1011/47 Is systemic or tissue coagulation a prognostic indicator in Cancer 47 12/NW/0090 Feasibility trial of a respiratory symptom intervention 48 12/YH/0248 An OpenLabel, Multicenter, Singlearm Study to Evaluate the Reduction in Nonpsychotic Behavioral Side Effects in Subjects with Epilepsy Switching from Levetiracetam to Brivaracetam due to Nonpsychotic Behavioral Side 24/05/13 N/A No patients 03/07/13 N/A Permissions ed 31/05/13 N/A Contracting s 22/08/12 31/10/12 N/A 04/03/13 30/04/13 N/A 19/02/13 19/04/13 N/A 21/02/13 08/04/13 N/A 13/03/13 05/06/13 Permissions ed 14/05/13 17/06/13 N/A 14/06/13 N/A Sponsor 03/05/13 N/A Rare disease 16/11/12 N/A No patients

6 Effects 49 12/WM/0268 Phase II/III in fingolimod vs placebo in patients with CIDP 50 12/LO/1679 Safety and Efficacy of 3 doses of MT1303 over 24 weeks in RRMS 51 12/NW/0387 Right Ventricular Pacing And Ventricular Dysfunction(RVPAVD Study): Pathophysiological Mechanisms and Predictors of Progression To Biventricular Dysfunction Following Right Ventricular Pacing 52 13/LO/0736 GP15302: Randomised Study To Compare GP2015 and Enbrel in Psoriasis 53 13/EE/0038 Tranexamic acid for the treatment of gastrointestinal haemorrhage: an international randomised, double blind placebo controlled trial 54 12/NW/0790 The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multicentre randomised controlled trial 55 13/LO/0072 A Randomized, Double blind, Placebo controlled,phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis 56 12/NW/0361 A pragmatic randomised controlled trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: (SANADII) 23/01/13 N/A No patients consented 25/03/13 22/05/13 N/A 15/08/13 N/A No patients 10/06/13 N/A Sponsor 28/06/13 06/09/13 Sponsor 03/07/13 N/A No patients consented 06/08/13 27/09/13 N/A 03/08/13 06/09/13 N/A

Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 July June 2013

Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 July 2012-30 June 2013 Name of trial Note, some study titles are shortened 1 Long-Term Study