ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 3 Study of RPC1063 in Relapsing MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: RPC1063 Drug: Beta interferon Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 1346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 3, 2014
Actual Primary Completion Date : December 22, 2016
Actual Study Completion Date : December 22, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.5 mg RPC1063 oral capsule
0.5 mg RPC1063 oral capsule daily, matching weekly IM placebo
Drug: RPC1063
Experimental: 1 mg RPC1063 capsule
1 mg RPC1063 capsule daily, + weekly IM placebo injection
Drug: RPC1063
Active Comparator: Beta interferon IM injection weekly
Beta interferon IM injection weekly, + daily oral placebo
Drug: Beta interferon



Primary Outcome Measures :
  1. Annualized relapse rate [ Time Frame: 12 - 30 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294058


  Show 224 Study Locations
Sponsors and Collaborators
Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02294058     History of Changes
Other Study ID Numbers: RPC01-301
2014-002320-27 ( EudraCT Number )
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by Celgene:
MS
RMS
Multiple Sclerosis
Relapsing Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs