Overview

This trial is active, not recruiting.

Condition relapsing multiple sclerosis
Treatments rpc1063 0.5 mg, rpc1063 1 mg, rpc1063 placebo, interferon β-1a, ifn β-1a placebo
Phase phase 3
Sponsor Celgene
Start date November 2013
End date April 2017
Trial size 1200 participants
Trial identifier NCT02047734, 2012-002714-40, RPC01-201 (Part B)

Summary

The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
rpc1063 0.5 mg
oral capsule, daily for 24 months
ifn β-1a placebo
intramuscular injection, weekly for 24 months
(Experimental)
rpc1063 1 mg
oral capsule, daily for 24 months
ifn β-1a placebo
intramuscular injection, weekly for 24 months
(Active Comparator)
rpc1063 placebo
oral capsule, daily for 24 months
interferon β-1a
intramuscular injection, 30 µg, weekly for 24 months

Primary Outcomes

Measure
Annualized relase rate (ARR) at the end of Month 24
time frame: Month 24

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria - EDSS score between 0 and 5.0 at baseline Exclusion Criteria: - Primary progressive multiple sclerosis

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Celgene.