An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.
The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.
Inclusion Criteria:
Exclusion Criteria:
Exclusions Related to General Health:
Exclusions Related to Medications:
Exclusion related to Shorter Infusion Substudy:
- Any previous serious IRRs experienced with ocrelizumab treatment
Stamford, Connecticut 06905, United States
Baltimore, Maryland 21201, United States
Tacoma, Washington 98405, United States
Milwaukee, Wisconsin 53215, United States
Nedlands, Western Australia 6009, Australia
Innsbruck, 6020, Austria
Salzburg, 5020, Austria
Aalborg, 9000, Denmark
Dresden, 01307, Germany
Erbach/Odenwald, 64711, Germany
Kassel, 34121, Germany
Kiel, 24105, Germany
München, 81675, Germany
Szeged, 6725, Hungary
Naples, Campania 80131, Italy
Naples, Campania 80131, Italy
Trieste, Friuli Venezia Giulia 34149, Italy
Rome, Lazio 00133, Italy
Milan, Lombardy 20132, Italy
Milan, Lombardy 20133, Italy
Pozzilli, Molise 86077, Italy
Catania, Sicily 95123, Italy
Palermo, Sicily 90146, Italy
Florence, Tuscany 50134, Italy
Mexico, Tlaxcala 06726, Mexico
Sittard-Geleen, 6162 BG, Netherlands
Lørenskog, 1478, Norway
Gdansk, 80-803, Poland
Bratislava, 813 69, Slovakia
Bratislava, 826 06, Slovakia
Santa Cruz de Tenerife, Tenerife 38010, Spain
Istanbul, 34098, Turkey (Türkiye)
London, WC1N 3BG, United Kingdom