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

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Ambrose Caldwell
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1 Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 July June 2013 Name of trial Note, some study titles are shortened 1 Long-Term Study for Extended BMN 701Treatment of Patients with Pompe Disease who have Completed BMN 701 Studies 2 Prospective, randomized, placebocontrolled, doubleblind, multicenter, parallel study to assess the efficacy, safety and tolerability of macitentan in s with ischemic digital ulcers associated with systemic sclerosis. 3 A Doubleblind, Randomized, Placebo Controlled, Dose Ranging Study To Evaluate The Efficacy And Safety Of Pf In Subjects With Crohn?S Disease Who Are Anti-Tnf Inadequate Responders (Andante) 4 An Open Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry Disease 5 Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) 6 A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY The effect of lateral wedge insoles on structural changes in the knee in individuals with medial knee osteoarthritis. The INSOLE study. 8 A Phase 2, Openlabel, Multinational Study to Evaluate the Efficacy and Safety of BMN 110 in Patients with Mucopolysaccharidosis IVA (Morquio A Syndrome) Who Have Limited Ambulation Research Ethics Committee reference number Date of receipt of valid research application Date of first recruited Reason for not achieving benchmark 12/NW/ /08/ /12/2012 Staff 11/LO/ /06/ /03/2013 Staff 11/NE/ /01/2012 Suspended by Sponsor 11/LO/ /02/ /07/2012 Rare 09/H0505/71 31/10/2011 No s 12/EE/ /02/2012 NHS permission /No s 11/NW/ /05/2012 Other 12/EE/ /05/ /05/2013 Rare

2 9 A single blind, randomised, crossover study investigating the effect of subcutaneous administration of the lucagonlike peptide1 agonist, exenatide, on central GLP1 receptor activation assessed by magnetic resonance imaging. 10 Setting up Functional Electrical Stimulation (FES) systems in a rehabilitation setting, for treatment of the upper limb post stroke: an exploratory study. 11 A randomized, double-blind, placebocontrolled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction s with elevated hscrp 12 Sensorimotor conflict and its relationship to behavioural and neurophysiological variables in CRPS, FMS,arthritis and healthy volunteers 13 A single arm, openlabel, phase II, multicentre study, to assess the safety of vismodegib (GDC0449) in s with locally advanced or astatic basal cell carcinoma (BCC) 14 A Randomized, Doubleblind, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ in the Treatment of Patients With Diarrhea- Predominant Irritable Bowel Syndrome 15 A Multicenter, Randomized, DoubleBlind, Placebo Controlled Study Comparing the Efficacy and Safety of LY to Etanercept and Placebo in Patients with Moderate to Severe Plaque Psoriasis 16 Enhanced Control of Hypertension and Thrombolysis Stroke Trial 17 HERO:Hydroxychloroquine Effectiveness in Reducing Symptoms of hand OA, a randomised, doubleblind, placebocontrolled trial 18 A Phase IIb, DoubleBlind, Randomized, PlaceboControlled, DoubleDummy, DoseRanging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS in Subjects with Moderate to Severe Crohn's Disease 12/NW/ /06/ /09/2012 NHS permission 12/NW/ /07/ /03/2013 Staff 12/EM/ /06/ /11/2012 Other 11/SW/ /09/ /10/2012 Other 11/EE/ /08/ /12/2012 Rare 12/WM/ /08/ /06/2013 No s consented 12/EE/ /10/ /04/2013 Staff &Sponsor 11/YH/ /09/ /01/2013 Sponsor 12/YH/ /07/ /03/2013 Contracting 12/EM/ /09/2012 Closed by sponsor

3 19 Randomised phase IV placebo controlled comparative study to evaluate the efficacy and safety of tapering hotrexate (MTX) dosage vs. Maintaining the dosage in s with severe active rheumatoid arthritis 20 A Phase III Trial of Prophylactic Irradiation of Tracts in Patients with Malignant Pleural Mesolthelioma Following Invasive Chest Wall Intervention. 21 Randomised controlled trial of oral supplements in weight losing colorectal cancer s. 22 A phase 4 prospective exploratory muscle biopsy, biomarker, and imaging assessment study in s with late-onset Pompe disease treated with alglocosidase alpha 23 A randomised, controlled crossoverstudy of deep brain stimulation for severe, intractable Gilles de la Tourette Syndrome 24 A Randomized, DoubleBlind,PlaceboControlled,Multicenter, ParallelGroup Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (=16 To 80 Years Old) With Partial Onset Seizures 25 Study to Investigate the Safety, Tolerability, Mechanism of Action and Exploratory Clinical Efficacy of Repeat DoseHF1020 in Patients with Moderate to Severe Psoriasis 26 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 Partial Onset Seizures 27 An OpenLabel,Multicenter, Follow UpStudy to Evaluate the LongTerm Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older with Epilepsy 28 A multicentre, extension study of subcutaneous secukinumab in prefilled syringes to demonstrate longterm efficacy, safety and tolerability up to 2 years in subjects with moderate to severe chronic plaquetype psoriasis 12/EE/ /07/ /02/2013 Sponsor 12/NW/ /NM/ /09/ /07/2013 Contracting 17/10/ /02/2013 No s 11/NE/ /07/2012 Rare 08/H1211/142 06/11/ /02/2013 No s 11/NE/ /10/ /01/2013 Sponsor 12/NW/ /06/ /01/2013 No s 11/NE/ /10/2012 Sponsor 12/YH/ /10/2012 Sponsor 12/ES/ /10/ /01/2013 No s 29 ANDANTE ii 11/NE/ /09/2012 Suspended by Sponsor

4 30 Queen Elizabeth physiotherapy post lumbar discectomy Study: pilot work to improve service delivery and inform the development of a randomised controlled trial QUEST 31 A multicentre,randomised, doubleblind,placebocontrolled, dose ranging study to evaluate the safety and efficacy of GSK in s with chronic plaque psoriasis 32 Double Blind, Randomized, Placebo Controlled, 8Week Study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis. 33 Does oral sodium bicarbonate therapy improve function and quality of life in older s with chronic kidney disease and low-grade acidosis? A multicentre randomized placebo controlled trial 34 The Fistula-In-Ano trial comparing Surgisis anal fistula plug versus surgeon's preference for transsphincteric fistula-in-ano 35 Tranexamic Acid for the treatment of significant traumatic brain injury: an international, randomised, double blind, placebo controlled trial. 36 A Cerebrospinal Fluid Collection Study in Paediatric and Adult Patients with Hunter Syndrome 37 Effects of intragastric glucose and fructose on gastric emptying and concentrations of blood glucose, fructose, insulin and glucagon-like peptide-1 38 Assessment of the efficacy and safety of a new wound dressing in the local treatment of diabetic foot ulcers: A Prospective, randomised, controlled, double-blind, European multi-centre clinical trial. 39 A randomised, double-blind, parallel-, 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 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 12/WM/ /09/ /01/2013 Contracting 12/NW/ /11/ /04/2013 Sponsor 12/LO/ /01/2013 No s 12/ES/ /10/ /05/2013 NHS 10/H0405/29 27/09/2012 Staff 12/EE/ /01/ /05/2013 NHS 11/NW/ /11/ /04/2013 Staff 12/NW/ /01/ /04/2013 NHS permissions 12/YH/ /12/2012 Patients not 08/H0906/140 21/03/2013 Other 13/LO/ /03/ /07/2013 Staff

5 (GHD) of adult onset 41 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 42 Phase III RIALTO: A Randomised Investigation of Alternative Ofatumumab containing regimens in less fit s with CLL 43 A Multicenter, Randomized, Placebo- Controlled Study of SBC-102 in Patients with Lysosomal Acid Lipase Deficiency 44 Study MAG104615, A Proof of Concept Study for GSK versus placebo in Stroke Patients 45 Effect of Lateral WEDGE insoles on Osteoarthritis knee pain and joint loading. The WEDGE study 46 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 47 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 48 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 49 SPIRiT: Serum Phosphate Intervention in Renal Replacement Therapy 50 A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atorvastatin versus Ezetimibe Added-on to Atorvastatin versus 51 Medial and Lateral Antebrachial Cutaneous Nerve Conduction Studies in Normal subjects Establishment of Normative Data. 12/EE/ /01/ /06/2013 Patients not 11/NW/ /06/2012 NHS 12/EE/ /03/2013 Patients not 13/LO/ /05/2013 Patients not 13/NW/ /05/2013 Staff 13/SC/ /05/2013 Sponsor 13/LO/ /05/2013 Patients not 12/SS/ /05/2013 Patients not 13/EM/ /07/2013 NHS 12/EE/ /05/2013 Contracting 12/NW/ /07/ /08/2012 Benchmark

6 52 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 53 Unravelling the underlying mechanisms of dysphagia in Stroke and neurodegenerative disease models with neuroimaging. 54 Tranexamic acid for IntraCerebral Haemorrhage TICH2 55 Real time electrophysiological model of ongoing pain for neurofeedback applications 56 Delivering a Mouth Hygiene Complex Intervention for Stroke Unit Care: A Pilot Study 57 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 s with Active Psoriatic Arthritis. 12/WS/ /08/ /10/2013 Sponsor 12/NW/ /EM/ /NW/ /NW/ /EM/ /03/ /04/2013 Benchmark 19/02/ /04/2013 Benchmark 21/02/ /04/2013 Benchmark 13/03/ /06/2013 Benchmark 14/05/ /06/2013 Benchmark

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

Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 October 2012-30 September 2013 Research Ethics Committee reference number Name of Trial 1 12/NW/0321