Clinical trial NCT02047734
Conditions: Relapsing Multiple Sclerosis
Sponsor: Celgene
Start date: 2013-12-03; Completion date: 2017-04-13
Enrollment: 1320 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.

The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).

Detailed description:
This clinical trial (RPC01-201; RADIANCE) consisted of 2 parts, each reported separately on ClinicalTrials.gov: Part A (NCT01628393) and Part B (this record).

Part A was a phase 2 study in which two doses of ozanimod were administered daily for 24 weeks with an efficacy and safety comparison to a placebo control and is reported separately as ClinicalTrials.gov record NCT01628393.

Part B, reported herein, was a phase 3 study in which two doses of ozanimod were administered daily for a 24 month period compared to an active control, interferon β-1a. Participants were allowed to enroll in the open-label extension study RPC01-3001 (NCT02576717) or complete the study with a safety follow-up visit 28 days after their last dose of study treatment.

Arms: arm 1: Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months. arm 2: Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months. arm 3: interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.
Interventions: intervention 1: Ozanimod intervention 2: Ozanimod placebo intervention 3: Interferon beta-1a intervention 4: Interferon beta-1a placebo
Intervention descriptions: intervention 1: Oral capsule, daily for 24 months intervention 2: Oral capsule, daily for 24 months intervention 3: Intramuscular injection, 30 µg, weekly for 24 months intervention 4: Intramuscular injection, weekly for 24 months

Protocol documents:
Prot_000.pdf: 
 
 
 
 
 
Protocol 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 
 
NCT Number:  NCT02047734 
Original Protocol Date:  04 October 2014 


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DISCLOSURE
REDACTED STATYSTICAL ANALYSIS PLAN PART B VERSION 2.0 
RPC01-201
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 
The information contained in the attached report is the property of Celgene and should not be shared or 
used for any purpose other than that for which it was provided. 
Celgene is committed to providing information about its clinical trials to researchers and patients with the 
goal of furthering science and enhancing healthcare worldwide.  Laws and regulations require, however, 
that Celgene protects patient privacy.  The company may further have legal or contractual obligations not 
to disclose commercial or technical information provided by or related to certain partner companies or 
vendors. 
The attached report is presented in its original format, but certain information has been redacted in order 
to comply with the aforementioned obligations or to protect Celgene’s confidential commercial 
information.  The redactions are based on the following principles: 
x
Redacted information has been replaced by grey space, maintaining original spacing and pagination. 
x
Any information that might allow the identification of individuals has been redacted for 
anonymization.  
x
Attachments to this report that contain confidential information are not made available.  Such 
attachments include those that contain identifiable patient information, such as subject listings, 
narratives, and profiles.  They also may contain confidential commercial information such as 
methodologies, and hypothesis generating and exploratory analyses. 
x
Cross-references to these attachments (such as links to subject listings in Section 16.2) are not 
redacted from the body of the report.  However, the hyperlinks in the electronic document are no 
longer functional. 
x
Information about Celgene vendors and their services are redacted because many contracts prohibit 
disclosure of that information.  Further, laws and regulations prevent us from disclosing certain 
information about our vendors or their services because it is protected by copyright. 
Information about Celgene’s redaction policies and the availability of additional data from this report may 
be found at http://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/.
CELGENE PROPRIETARY INFORMATION
E-
HE
HE
APSING 
APSING
d not be sha
not be sh
earchers and
archers an
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ati
legal or c
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cation 
tain confide
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hesis genera
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ody of the re
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bout Celgen
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of that inform
f that info
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on about o
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ation about 
ound at http
ound at http


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Other Important Considerations
5.4.1.
Definition of Baseline 
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Demographics
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Medical History
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TREATMENTS AND MEDICATIONS 
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9.1
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9.1.2.
Sensitivity Analysis 
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9.2.
Key Secondary Efficacy Endpoints
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9.2.1.
Analysis 
Key Secondary Endpoint: The number of new or enlarging hyperintense T2-
weighted brain MRI lesions over 24 months 
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Key Secondary Endpoint: Time to onset of disability progression as defined by a 
sustained worsening in EDSS of 1.0 points or more, confirmed after 3 months and 
after 6 months 
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9.3.1.
Analysis 
Secondary Endpoints: The proportion of patients who are GdE lesion-free at Month 
24, and the proportion of patients who are T2 lesion-free at Month 24 
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Secondary Endpoint: Change in normalized brain volume (atrophy) on MRI scans 
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Clinical Laboratory Evaluations
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Hematology 
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Blood Chemistry 
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Urinalysis 
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Vital Sign Measurements
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Electrocardiogram
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Pulmonary Function Testing
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Physical Examination
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Chest X-ray
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Suicidality
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Other Assessments
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12.
REFERENCES
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YV*ODWLUDPHU$FHWDWHLQ5HODSVLQJ06'LVHDVH>5(*$5'@VWXG\DPXOWLFHQWHU
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1LFKRODV56WUDXEH66FKPLGOL+HWDO7UHQGVLQDQQXDOL]HGUHODSVHUDWHVLQ
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