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Phase 3 Study of RPC1063 in Relapsing MS

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ClinicalTrials.gov Identifier: NCT02294058
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

August 5, 2014
November 19, 2014
May 8, 2017
December 3, 2014
December 22, 2016   (Final data collection date for primary outcome measure)
Annualized relapse rate [ Time Frame: 12 - 30 Months ]
Same as current
Complete list of historical versions of study NCT02294058 on ClinicalTrials.gov Archive Site
Not Provided
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Phase 3 Study of RPC1063 in Relapsing MS
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
The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS).
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).
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: RPC1063
  • Drug: Beta interferon
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1346
1200
December 22, 2016
December 22, 2016   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
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
Argentina,   Austria,   Colombia,   Czech Republic,   Mexico,   Peru
 
NCT02294058
RPC01-301
2014-002320-27 ( EudraCT Number )
Yes
Not Provided
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Celgene
Celgene
Not Provided
Not Provided
Celgene
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP