Table 2: Salford Royal NHS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January December 2014
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1 Table 2: Salford Royal HS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January December 2014 Research Ethics Committee reference number 1 12/W/ /LO/ /LO/ /EE/ /EE/ /WM/ /EE/0089 ame of Trial Target number of patients Date agreed to recruit target number of patients Trial status Target met within the agreed time A long-term study for extended BM 701treatment of patients with Pompe disease who have completed BM 701 Studies 1 01/12/2012 Prospective, randomized, placebo controlled, double blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic Closed - digital ulcers associated with systemic sclerosis. 8 01/12/2013 complete An open label extension study to evaluate the long-term safety and efficacy of Migalastat Hydrochloride monotherapy in subjects with Fabry disease 2 31/12/2015 Open /A A 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 L in patients with psorasis 5 15/11/2017 Open /A A phase 2, open label, multinational study to evaluate the efficacy and safety of BM 110 in patients with mucopolysaccharidosis IVA (Morquio A syndrome) who have limited ambulation 1 30/06/2014 A randomized, double blind, placebo controlled, phase 3 study to evaluate the efficacy, safety, and tolerability of JJ in the treatment of patients with diarrhea-predominant Irritable Bowel Syndrome 0 01/06/2013 A multicenter, randomized, double blind, placebo controlled study comparing the efficacy and safety of L to Etanercept and placebo in patients with moderate to severe plaque psoriasis 5 01/12/2013 Closed - complete
2 8 12/EM/ /EE/ /E/ /E/ /H/0249 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safety of induction and maintenance therapy with BMS in subjects with moderate to severe Crohn's disease 3 01/01/2014 Withdrawn /A Randomised, phase IV, to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) 4 01/12/2013 Open /A A phase 4 prospective exploratory muscle biopsy, biomarker, and imaging assessment study in patients with late-onset Pompe disease treated with alglocosidase alfa 1 15/07/2013 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 3 30/06/2013 An open label, multicenter, study to evaluate the long-term safety and efficacy of Brivaracetam used as treatment in aged 16 years or older with epilepsy 3 28/11/2012 Open /A A multicentre, double blind, extension study of subcutaneous secukinumab in prefilled syringes to demonstrate long-term efficacy, safety and tolerability up to two years 13 12/ES/0074 in subjects with moderate to severe chronic plaque type psoriasis 1 01/12/ /E/0301 ADATE ii Withdrawn /A 15 12/W/ /LO/ /W/0502 A multicentre, randomised, double blind, placebo controlled, dose ranging study to evaluate the safety and efficacy of GSK in patients with chronic plaque psoriasis 4 01/07/2013 Double blind, randomized, placebo controlled, eight-week study investigating the safety, pharmacokinetics and pharmacodynamics of SAR given orally to patients with diffuse cutaneous systemic sclerosis. 0 01/11/2013 A cerebrospinal fluid collection study in paediatric and adult patients with 1 01/03/2013
3 Hunter syndrome 18 12/H/ /H0906/ /LO/ /EE/ /EE/ /LO/ /SC/ /LO/ /EE/0532 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 multicentre clinical trial. 6 16/04/2016 Open /A 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. DIAS /12/2014 Closed - complete Open label, single arm, phase IV, multicentre trial to explore the immunogenicity of the liquid formulation of Saizen in subjects with growth hormone deficiency (GHD) of adult onset 1 01/09/2014 Open /A A randomized, double-blind study of the efficacy and safety of REG727 added-on to Rosuvastatin versus Ezetimibe added-on to Rosuvastatin versus Rosuvastatin dose increase in patients who are not controlled on Rosuvastatin 3 24/06/2013 A multicenter, randomized, placebocontrolled study of SBC-102 in patients with lysosomal acid lipase deficiency 2 Open /A Study MAG104615, a proof of concept study for GSK versus placebo in stroke patients 5 01/10/2014 Open /A A multicenter, 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 6 01/09/2013 Open /A A randomized, double blind, double dummy, active controlled study to evaluate the efficacy and safety of REG727/SAR in patients with primary hpercholesterolemia who are intolerant to statins 3 26/07/2013 A randomized, double-blind study of the efficacy and safety of REG727 added-on to Atorvastatin versus Ezetimibe added-on to Atorvastatin 1 24/06/2013
4 27 12/WS/ /EM/ /LO/ /WM/ /H/ /LO/0072 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 2 01/02/2013 A phase III study of subcutaneous Secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long-term efficacy, safety and tolerability up to 5 years in patients with ative psoriatic arthritis. 4 01/07/2014 Open /A Safety and efficacy of three doses of MT /01/2015 Open Phase II/III in fingolimod vs placebo in patients with CIDP 2 30/04/2014 Open An open label, multicenter, single arm study to evaluate the reduction in nonpsychotic behavioral side effects in subjects with epilepsy switching from Levetiracetam to Brivaracetam due to nonpsychotic behavioral side effects 4 31/05/2014 Open /A 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 2 31/12/2013 A randomized, double blind,multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar etanercept (GP2015) and Enbrel in 33 13/LO/0736 patients with moderate to severe chronic plaquetype psoriasis /SC/0077 METOP 10 31/08/2014 Open /A 35 13/EE/0241 ovartis CAI457AGBOI 2 09/10/ /W/ /LO/ /WA/ /W/0560 Efficacy and safety/tolerability of subcutaneous SCH900222/MK /01/2014 Momentum study extension - MT E05 2 In set up /A A study of Ixekizumab in patients with psoriatic arthritis 4 30/04/2014 Open /A Effect of passive immunization on the progression of mild Alzheimer s disease: Solanezumab (L ) versus placebo 10 19/08/2015 Open /A
5 40 13/W/ /W/ /EE/ /SC/0558 Pregabalin in subjects with primary generalised tonic-clonic seizures 2 31/08/2016 Open /A Study of oral Laquinimod in subjects with multiple sclerosis 4 28/02/2015 Open /A BEL A two- year mechanistic study of belimumab in idiopathic membranous glomerulonephropathy 1 Open /A CAI457A3301 Secukinumab in treatment of chronic palmoplantar pustular psoriasis 4 12/12/2014 Open /A 44 12/W/0386 A two-part, phase 1 single-dose study to assess doses of IL-31 mab 8 Open /A 45 12/E/0410 MK /11/2015 Open /A 46 14/H/0005 IMPERIUM (IOQL) 5 28/02/2015 Open /A 47 14/W/0005 A randomised, double blind, placebo controlled proof of concept study of the efficacy of gevokizumab 60 mg subcutaneously every four weeks over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease 3 31/12/2014 Open /A 48 13/SS/0224 A multicenter, double blind, randomized, placebo controlled, dose response trial of KP3089 as adjunctive therapy in subjects with partial onset seizures, with optional open label extension Open /A 49 13/WA/0084 A randomised, double blind, placebo controlled, multicenter study to assess cardiovascular outcomes following treatment with MK3102 in subjects with type two diabetes mellitus 7 10/10/2014 Open /A 50 13/LO/1520 Study of diabetic nephropathy with Atrasentan 6 30/04/2014 Open /A 51 13/EM/0248 TOPIX 4 Open /A 52 14/H/0049 CLOTBUSTER 18 31/03/2015 Open /A 53 14/W/0017 TERI-PRO 6 30/11/2014 Open /A 54 14/EM/0032 CAI457A2317 Efficacy of secukinumab compared to ustekinumab in moderate/severe psoriasis. 4 01/07/2014 Open /A 55 14/EM/0024 CAI457F2318 Efficacy and safety of secukinumab in patients with psoriatic arthritis 3 22/01/2018 Open /A 56 13/EM/0423 GWP42004 in type two diabetes 6 30/04/2015 Open /A 57 13/WM/037 3 BM701 Phase 3 in rhgaa exposed subjects with late onset Pompe disease 2 31/03/2015 Open /A 58 14/SC/ DIA4003 (CAVASR) 8 30/06/2015 Open /A
6 59 13/SC/0616 COPD exacerbation vaccine study 14 31/01/2015 Suspended /A 60 14/SC/ SUSTAI Semaglutide versus basal insulin in type two diabetes 5 31/12/2014 Open /A 61 11/W/0782 POUT Open /A 62 14/W/0055 Pregabalin open label study of A /02/2017 Open /A 63 13/E/0263 A phase III Tofacitinib for active PsA 4 30/11/2015 Open /A 64 14/H/0133 Challenge EXUFIBER 10 26/01/2015 Open /A 65 12/E/0343 OPE trial 5 30/10/2014 Open /A 66 13/LO/1758 A safety and efficacy study of MK8931 for prodromal AD 8 29/02/2016 Open /A 67 14/EE/0076 ASSURE 10 30/04/2015 Open /A 68 14/H/0132 The PSOABLE trial 6 28/02/2015 Open /A 69 14/LO/0521 EESTPath - Switching to, then stopping treatment with ilotinib for CML patients 3 31/12/2014 Open /A 70 14/EM/0073 MK8835/PF versus placebo in T2DM subjects with stage three chronic kidney disease 3 31/07/2015 Open /A 71 14/EM/0106 CBM338B RESILIET 8 16/11/2015 Open /A 72 14/E/1018 Benralizumab treatment in moderate to very severe COPD - GALATHEA 2 18/07/2016 Open /A 73 14/W/0008 GOCOLITIS 6 31/03/2015 Open /A 74 14/LO/0471 Pulmaquin with non cystics fibrosis bronchiesctasis (ORBIT 4) 2 31/03/2015 Open /A 75 14/SC/1059 The CREDECE trial 8 31/03/2016 Open /A 76 14/LO/1461 Actelion AC-065C202: Raynaud s phenomenon secondary to systemic sclerosis 6 31/01/2015 Open /A 77 14/SW/ MS305-Fampridine in subjects with multiple sclerosis (EHACE) 6 31/08/2015 Open /A 78 11/EE/0210 CCX /06/2015 Open /A 79 14/EE/1096 Fabry SRFT MOO 1 01/06/2015 Open /A 80 14/H/1090 QUIET 1 - The Quest in Eliminating Tinnitus 10 01/06/2015 Open /A 81 13/SW/0132 MASTER 1 31/03/2017 Open /A 82 14/H/ /W/ /SC/0153 Cadazolid /ACT Clostridium difficile associated diarrhoea(cdad) 5 31/07/2016 Open /A Dupilumab moderate-severe atopic dermatitis 2 31/01/2016 Open /A The PATH study- Two different doses of IgPro20 for the treatment of CIDP 3 01/10/2015 Open /A
Table 2: Salford Royal NHS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January 31 December 2015
Research Ethics Committee reference number Table 2: Salford Royal NHS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January 31 December 2015 Name of trial 1 11/LO/1823
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
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 April March 2014
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 April 2013-31 March 2014 Research Ethics Committee Name of Trial reference number 1 08/H0906/140
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
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Target date to recruit patients agreed? Target range minimum. Target range maximum. Agreed 1 1 Agreed 01/01/ /01/2016 Recruitment Finished
No REC Reference IRAS No Title Target number of patients agreed? Target range minimum Target range maximum Target date to recruit patients agreed? Planned Recruitment end date No of patients recruited
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The Pennine Acute Hospitals NHS Trust Performance in initiating clinical research Reporting period 1 October 2017 to 30 September 2018
The Pennine Acute Hospitals NHS Trust Performance in initiating clinical research Reporting period 1 October 2017 to 30 September 2018 REC reference IRAS reference Name of trial First patient recruited?
Target date to recruit patients agreed? Target range. maximum. minimum. Date. 5 Agreed 26/01/ /11/2015 Recruitment Finished.
No REC Reference IRAS No Title Target number of agreed? Target range minimum Target range maximum Target date to recruit agreed? Planned Recruitment end date Total no of recruited at the agreed target
Target date to recruit patients agreed? Target range minimum. Target range maximum
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