Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Relapsing Multiple Sclerosis

In brief

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).

Key facts

Study ID

NCT01628393

Run by

Celgene

People needed

258

Starts

2012-09-18

Expected to finish

2016-05-11

Last updated by the study team

2021-02-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
• Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at Baseline

You may not qualify if…

• Secondary or primary progressive multiple sclerosis

Where it is running

• Neuro Pain Medical Center — Fresno, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• The Neurological Institute PA — Charlotte, North Carolina, United States
• Neurology and Neuroscience Associates Inc. — Akron, Ohio, United States
• The Polyclinic — Seattle, Washington, United States
• Cliniques Universitaires St-Luc — Brussels, Belgium
• Centre Hospitalier Chretien Clinique Saint Joseph — Montegnée, Belgium
• Clinique Saint-Pierre — Ottignies, Belgium
• University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD — Sofia, Bulgaria
• Sarajishvili Institute of Neurology — Tbilisi, Georgia
• LTD MediClubGeorgia — Tbilisi, Georgia
• Khechinashvili University Hospital — Tbilisi, Georgia
• Evaggelismos General Hospital — Athens, Greece
• 401 Military Hospital of Athens — Athens, Greece
• Georgios Papanikolaou General Hospital of Thessaloniki — Thessaloniki, Greece
• Vaszary Kolos Korhaz — Esztergom, Hungary
• Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele — Cantania, Italy
• Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi — Czeladź, Poland
• Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego — Grudziądz, Poland
• Novo-Med Zielinski i wsp. Sp.J. — Katowice, Poland
• NEURO- CARE Site Management Organization Gabriela Klodowska-Duda — Katowice, Poland
• NEURO MEDIC Janusz Zbrojkiewicz — Katowice, Poland
• RESMEDICA Spolka z o.o. — Kielce, Poland
• Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny — Konstancin-Jeziorna, Poland
• Alta Bates Summit Medical Center — Berkeley, California, United States

Full record on ClinicalTrials.gov

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