Clinical trial NCT01628393
Conditions: Relapsing Multiple Sclerosis
Sponsor: Celgene
Start date: 2012-09-18; Completion date: 2016-05-11
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734).

The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).

Detailed description:

Arms: arm 1: Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 0.5 mg weekly for another 96 weeks. arm 2: Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 1 mg weekly for another 96 weeks. arm 3: Participants received placebo to ozanimod oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and were randomized to receive ozanimod 0.5 mg or 1 mg weekly for 96 weeks.
Interventions: intervention 1: Ozanimod intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsule taken once a day intervention 2: Oral capsule taken once a day

Protocol documents:
Prot_001.pdf: 
 
 
 
 
 
Protocol Title:   
A Phase 2/3, Multi-center, Randomized, Double-blind, 
Placebo-controlled (Part A) and Double-blind, Double-
dummy, Active-controlled (Part B), Parallel Group Study to 
Evaluate the Efficacy and Safety of RPC1063 
Administered Orally to Relapsing Multiple Sclerosis 
Patients 
 
NCT Number:  NCT01628393 
Protocol Amendment Date:  01 October 2014 


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SAP_000.pdf: 
 
 
 
 
 
Protocol Title:   
A Phase 2/3, Multi-center, Randomized, Double-blind, 
Placebo-controlled (Part A) and Double-blind, Double-
dummy, Active-controlled (Part B), Parallel Group Study to 
Evaluate the Efficacy and Safety of RPC1063 
Administered Orally to Relapsing Multiple Sclerosis 
Patients 
 
NCT Number:  NCT01628393 
Statistical Analysis Plan 1.2 Part A Date:  20 May 2014 


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