A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Phase 1

• Conditions: Relapsing Multiple Sclerosis; MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-020337-99-FI
• Lead Sponsor: F.Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 821

Inclusion Criteria

Male and female patients between ages 18-55 with a diagnosis of relapsing multiple sclerosis
At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the year prior to screening (but not within 30 days prior to screening)
Patients with EDSS score of 0-5.5

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with other chronic disease of the immune system, malignancies or other diseases or conditions that could preclude patient from participating in the study.
Contraindications to or intolerance of oral or i.v. corticosteroids - Contraindication to or intolerance of interferon beta-1a (Rebif)
Pregnant or nursing women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified