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NCT01628393 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients
A Phase 2 study of Relapsing Multiple Sclerosis, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 258
- Enrollment target
- 20
- Study locations
NCT01628393: Completed Phase 2 study of Relapsing Multiple Sclerosis, sponsored by Celgene.
NCT01628393 is a Phase 2 study of Relapsing Multiple Sclerosis that has completed, run by Celgene. The registered enrollment target is 258 participants, below the 2,158-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01628393, a Phase 2 study of Relapsing Multiple Sclerosis, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 258 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734). The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).
Primary Outcome
The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ozanimod
Study Locations (20)
Other
- Cliniques Universitaires St-Luc - Brussels
- Centre Hospitalier Chretien Clinique Saint Joseph - Montegnée
- Clinique Saint-Pierre - Ottignies
- University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD - Sofia
- Sarajishvili Institute of Neurology - Tbilisi
- LTD MediClubGeorgia - Tbilisi
- Khechinashvili University Hospital - Tbilisi
- Evaggelismos General Hospital - Athens
- 401 Military Hospital of Athens - Athens
- Georgios Papanikolaou General Hospital of Thessaloniki - Thessaloniki
- Vaszary Kolos Korhaz - Esztergom
- Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Cantania
- Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi - Czeladź
- Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego - Grudziądz
California
- Alta Bates Summit Medical Center - Berkeley
- Neuro Pain Medical Center - Fresno
- University of California Davis Medical Center - Sacramento
North Carolina
- The Neurological Institute PA - Charlotte
Ohio
- Neurology and Neuroscience Associates Inc. - Akron
Washington
- The Polyclinic - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2012-09-18 |
| Est. Completion | 2016-05-11 |
| Phase | Phase 2 |
What the finished NCT01628393 record still lists
NCT01628393 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, below the 2,158-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01628393 names 20 study sites across 5 states, led by Other, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01628393 about?
NCT01628393 is a clinical study titled "Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients". This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734). The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enh...
What is the current status of trial NCT01628393?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2012-09-18. Estimated completion is 2016-05-11.
What conditions does trial NCT01628393 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis.
What interventions are being tested in trial NCT01628393?
The interventions under investigation include: Placebo (DRUG), Ozanimod (DRUG).
Who is sponsoring clinical trial NCT01628393?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01628393 being conducted?
This trial has 20 study locations across California, North Carolina, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Relapsing Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01628393's enrollment target sits among peer trials
258 14th of 23 higher than 10 of 23 other Relapsing Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsing Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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