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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

Study Description
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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 Design
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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


Arms and Interventions
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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


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

Eligibility Criteria
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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

Contacts and Locations
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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:
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Multiple Sclerosis
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