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History of Changes for Study: NCT02047734
Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis (Radiance Study)
Latest version (submitted January 25, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 26, 2014 None (earliest Version on record)
2 March 14, 2014 Contacts/Locations and Study Status
3 June 4, 2014 Contacts/Locations and Study Status
4 June 12, 2014 Contacts/Locations and Study Status
5 August 8, 2014 Contacts/Locations, Arms and Interventions and Study Status
6 September 24, 2014 Contacts/Locations and Study Status
7 October 21, 2014 Contacts/Locations and Study Status
8 November 17, 2014 Contacts/Locations and Study Status
9 December 10, 2014 Contacts/Locations and Study Status
10 January 21, 2015 Contacts/Locations and Study Status
11 February 18, 2015 Recruitment Status, Contacts/Locations and Study Status
12 March 18, 2015 Contacts/Locations and Study Status
13 April 6, 2015 Study Status
14 April 14, 2015 Study Status
15 May 4, 2016 Study Status, Contacts/Locations and Study Identification
16 September 27, 2016 Study Status
17 May 23, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Identification
18 May 24, 2017 Study Status and Contacts/Locations
19 April 4, 2018 Study Status
20 April 5, 2018 Arms and Interventions, Outcome Measures, Study Design, Study Status and Eligibility
21 June 5, 2019 Study Status
22 June 20, 2019 Arms and Interventions, References, Study Design, Study Description, Study Status and Study Identification
23 January 25, 2021 Outcome Measures, Arms and Interventions, Study Status, More Information, Study Description, Study Identification, Document Section, Adverse Events, Baseline Characteristics, Participant Flow and References
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Study NCT02047734
Submitted Date:  January 26, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: RPC01-201 (Part B)
Brief Title: Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis (Radiance Study)
Official 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
Secondary IDs: 2012-002714-40 [EudraCT Number]
Open or close this module Study Status
Record Verification: January 2014
Overall Status: Recruiting
Study Start: November 2013
Primary Completion: November 2017 [Anticipated]
Study Completion:
First Submitted: January 26, 2014
First Submitted that
Met QC Criteria:
January 26, 2014
First Posted: January 28, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 26, 2014
Last Update Posted: January 28, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Celgene
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine whether RPC1063 is effective in the treatment of relapsing multiple sclerosis (RMS).
Detailed Description:
Open or close this module Conditions
Conditions: Relapsing Multiple Sclerosis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 1200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: RPC1063 Low Dose Drug: RPC1063 low dose
oral, low dose, daily for 24 months
Drug: IFN β-1a placebo
intramuscular injection, weekly for 24 months
Experimental: RPC1063 High Dose Drug: RPC1063 high dose
oral, high dose, daily for 24 months
Drug: IFN β-1a placebo
intramuscular injection, weekly for 24 months
Active Comparator: Interferon β-1a Drug: RPC1063 placebo
oral, 1 capsule, daily for 24 months
Drug: Interferon β-1a
intramuscular injection, 30 µg, weekly for 24 months
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Annualized relase rate (ARR) at the end of Month 24
[ Time Frame: Month 24 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Jeffrey P Hartung, PhD
Telephone: +1 858-652-5736
Email: jhartung@receptos.com
Locations: United States, California
[Recruiting]
Berkeley, California, United States
[Not yet recruiting]
Fresno, California, United States
[Not yet recruiting]
Sacramento, California, United States
United States, Florida
[Recruiting]
Weston, Florida, United States
United States, North Carolina
[Recruiting]
Charlotte, North Carolina, United States
[Recruiting]
Raliegh, North Carolina, United States
United States, Ohio
[Recruiting]
Akron, Ohio, United States
[Recruiting]
Cleveland, Ohio, United States
United States, Pennsylvania
[Not yet recruiting]
Philadelphia, Pennsylvania, United States
United States, Washington
[Recruiting]
Seattle, Washington, United States
Belgium
[Recruiting]
Brugge, Belgium
[Recruiting]
Brussels, Belgium
[Recruiting]
Montegnée, Belgium
[Recruiting]
Ottignies, Belgium
[Recruiting]
Sijsele-Damme, Belgium
Bulgaria
[Recruiting]
Sofia, Bulgaria
Georgia
[Not yet recruiting]
Tbilisi, Georgia
Greece
[Recruiting]
Athens, Greece
[Recruiting]
Thessaloniki, Greece
Hungary
[Recruiting]
Nyíregyháza, Hungary
Italy
[Not yet recruiting]
Catania, Italy
[Not yet recruiting]
Cefalù, Italy
[Not yet recruiting]
Milano, Italy
Poland
[Not yet recruiting]
Bialystok, Poland
[Not yet recruiting]
Czeladz, Poland
[Not yet recruiting]
Grudziadz, Poland
[Not yet recruiting]
Katowice, Poland
[Not yet recruiting]
Kielce, Poland
[Not yet recruiting]
Konstancin-Jeziorna, Poland
[Not yet recruiting]
Krakow, Poland
[Not yet recruiting]
Lodz, Poland
[Not yet recruiting]
Lublin, Poland
[Not yet recruiting]
Olsztyn, Poland
[Not yet recruiting]
Plewiska, Poland
[Not yet recruiting]
Poznan, Poland
[Not yet recruiting]
Szczecin, Poland
[Not yet recruiting]
Warszawa, Poland
Romania
[Not yet recruiting]
Bucharest, Romania
[Not yet recruiting]
Campulung, Romania
[Not yet recruiting]
Cluj-Napoca, Romania
[Not yet recruiting]
Sibiu, Romania
[Not yet recruiting]
Timisoara, Romania
Russian Federation
[Not yet recruiting]
Kazan, Russian Federation
[Not yet recruiting]
Saransk, Russian Federation
Serbia
[Not yet recruiting]
Belgrade, Serbia
[Not yet recruiting]
Kragujevac, Serbia
[Not yet recruiting]
Nis, Serbia
Spain
[Recruiting]
Barcelona, Spain
[Recruiting]
Madrid, Spain
[Recruiting]
San Sebastián, Spain
[Recruiting]
Sevilla, Spain
[Recruiting]
Valencia, Spain
Ukraine
[Not yet recruiting]
Chernihiv, Ukraine
[Not yet recruiting]
Dnipropetrovsk, Ukraine
[Not yet recruiting]
Donetsk, Ukraine
[Not yet recruiting]
Kharkiv, Ukraine
[Not yet recruiting]
Kiev, Ukraine
[Not yet recruiting]
Lutsk, Ukraine
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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