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

Phase 3

Completed

• Conditions: Autoimmune disorder of the central nervous system; MS; 10007951

• Registration Number: NL-OMON43603
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

- adult patients, 18 - 55 years of age inclusive
- multiple sclerosis confirmed according to revised McDonald criteria (2010)
- relapsed-remitting or secondary progressive disease
- 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).
- Neurological stability for * 30 days prior to both screening and baseline
- EDSS, at screening, from 0 to 5.5 inclusive
Patients who meet the following entry criteria may participate in the OLE Phase:
-Complete the 96-week, double-blind, double-dummy treatment period, and who, in the opinion of the Investigator, may benefit from treatment with ocrelizumab;
-Are able and willing to provide written informed consent for the OLE Phase (e.g., before the first infusion at Cycle 5) and to comply with the study protocol;
-Are willing to continue to use at least two contraceptive methods;
-Meet re-treatment criteria with ocrelizumab (see Section 6.1.4).

Exclusion Criteria

1. Diagnosis of primary progressive MS.
2. Disease duration of more than 10 years in patients with an EDSS * 2.0 at screening.
3. Inability to complete an MRI
4. Known presence of other neurological disorders which may mimic MS.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is annualized protocol-defined relapse rate at<br /><br>two years (96 weeks). Protocol-defined relapse, is defined as the occurrence of<br /><br>new or worsening neurological symptoms attributable to MS. </p><br>