WHO ICTRP trial
A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With…
EUCTR2010-020337-99-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2010-020337-99-GB |
|---|---|
| Public title | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis |
| Scientific title | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I |
| Primary sponsor | F.Hoffmann-La Roche |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South… |
| Conditions | Relapsing Multiple Sclerosis MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System… |
| Interventions | Trade Name: Rebif Pharmaceutical Form: Solution for injection INN or Proposed INN: INTERFERON BETA-1A CAS Number: 220581-49-7 Concentration unit: µg microgram(s) Concentration type: range Concentration number: 8.8-22 Pharmaceutical form of… |
| Registration date | May 10, 2010 |
| Target size | 800 |
| Secondary IDs | WA21092;NCT01247324 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: