Clinical trial
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
Name
WA21093
Description
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
Trial arms
Trial start
2011-09-20
Estimated PCD
2015-05-12
Trial end
2022-12-30
Status
Completed
Phase
Early phase I
Treatment
Interferon beta-1a
Arms:
Interferon beta-1a 44 mcg SC
Other names:
Rebif
Ocrelizumab-matching placebo
Arms:
Interferon beta-1a 44 mcg SC
Ocrelizumab
Arms:
Ocrelizumab
Other names:
RO4964913
Interferon beta-1a-matching placebo
Arms:
Ocrelizumab
Size
835
Primary endpoint
Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period
Week 96
Eligibility criteria
Inclusion Criteria:
* Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
* At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
* Neurologic stability for greater than or equal to (\>/=) 30 days prior to both screening and baseline
* Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
Exclusion Criteria:
* Primary progressive multiple sclerosis
* Disease duration of more than 10 years in patients with EDSS score less than or equal to (\</=) 2.0 at screening
* Contraindications for MRI
* Known presence of other neurological disorders which may mimic multiple sclerosis
* Pregnancy or lactation
* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* History of or currently active primary or secondary immunodeficiency
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus \[HIV\], syphilis, tuberculosis)
* History of progressive multifocal leukoencephalopathy
* Contraindications to or intolerance of oral or IV corticosteroids
* Contraindications to Rebif or incompatibility with Rebif use
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 835, 'type': 'ACTUAL'}}
Updated at
2024-03-08
1 organization
2 products
1 indication
Organization
Hoffmann La RocheProduct
OcrelizumabIndication
Multiple SclerosisProduct
Interferon beta-1a