Phase 3 Study of RPC1063 in Relapsing MS

Tracking Information
First Submitted Date ICMJE	August 5, 2014
First Posted Date ICMJE	November 19, 2014
Last Update Posted Date	May 8, 2017
Actual Study Start Date ICMJE	December 3, 2014
Actual Primary Completion Date	December 22, 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 14, 2014)	Annualized relapse rate [ Time Frame: 12 - 30 Months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT02294058 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Phase 3 Study of RPC1063 in Relapsing MS
Official Title ICMJE	A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
Brief Summary	The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS).
Detailed Description	The purpose of this study is to learn about the effects and safety of experimental medication RPC1063 taken by mouth in the treatment of Relapsing Multiple Sclerosis (RMS).
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Multiple Sclerosis
Intervention ICMJE	Drug: RPC1063; Drug: Beta interferon
Study Arms	Experimental: 0.5 mg RPC1063 oral capsule 0.5 mg RPC1063 oral capsule daily, matching weekly IM placebo Intervention: Drug: RPC1063; Experimental: 1 mg RPC1063 capsule 1 mg RPC1063 capsule daily, + weekly IM placebo injection Intervention: Drug: RPC1063; Active Comparator: Beta interferon IM injection weekly Beta interferon IM injection weekly, + daily oral placebo Intervention: Drug: Beta interferon
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 4, 2017)	1346
Original Estimated Enrollment ICMJE; (submitted: November 14, 2014)	1200
Actual Study Completion Date	December 22, 2016
Actual Primary Completion Date	December 22, 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belarus, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Estonia, Georgia, Germany, Hungary, Latvia, Lithuania, Moldova, Republic of, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Sweden, Ukraine, United Kingdom, United States
Removed Location Countries	Argentina, Austria, Colombia, Czech Republic, Mexico, Peru
Administrative Information
NCT Number ICMJE	NCT02294058
Other Study ID Numbers ICMJE	RPC01-301; 2014-002320-27 ( EudraCT Number )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Celgene
Study Sponsor ICMJE	Celgene
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Celgene
Verification Date	May 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP