Overview

This trial is active, not recruiting.

Condition multiple sclerosis, relapsing-remitting
Treatments interferon beta-1a, methylprednisolone, ocrelizumab, placebo
Phase phase 2
Sponsor Genentech, Inc.
Collaborator Roche Pharma AG
Start date January 2008
End date September 2009
Trial size 221 participants
Trial identifier NCT00676715, 2007-006338-32, ACT4422g, WA21493

Summary

This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with RRMS.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
methylprednisolone
IV repeating dose
ocrelizumab
IV repeating dose
(Experimental)
methylprednisolone
IV repeating dose
ocrelizumab
IV repeating dose
(Placebo Comparator)
methylprednisolone
IV repeating dose
placebo
Intravenous repeating dose
(Active Comparator)
interferon beta-1a
Intramuscular repeating dose
methylprednisolone
IV repeating dose

Primary Outcomes

Measure
Total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain.
time frame: Weeks 12, 16, 20 and 24

Secondary Outcomes

Measure
Annualized protocol defined relapse rate
time frame: Week 24
Proportion of patients who remain relapse-free
time frame: Week 24
Change in total volume of T2 lesions on MRI scans of the brain
time frame: Baseline to week 24

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Ability to provide written informed consent and to be compliant with the schedule of protocol assessments - Relapsing-remitting MS - Ages 18-55 years inclusive - For sexually active female and male patients of reproductive potential, use of reliable means of contraception Exclusion Criteria: - Secondary or primary progressive multiple sclerosis at screening - Incompatibility with MRI - Contra-indications to or intolerance of oral or i.v. corticosteroids - Known presence of other neurologic disorders - Pregnancy or lactation - Lack of peripheral venous access - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies - Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal - Congestive heart failure - Known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening - History or known presence of recurrent or chronic infection - History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved) - History of alcohol or drug abuse within 24 weeks prior to randomization - History of or currently active primary or secondary immunodeficiency - History of coagulation disorders - Treatment with any investigational agent within 4 weeks of screening - Receipt of a live vaccine within 6 weeks prior to randomization - Incompatibility with Avonex use - Previous treatment with rituximab - Previous treatment with lymphocyte-depleting therapies except mitoxantrone - Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization - Treatment with beta interferons, glatiramer acetate, i.v. immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization - Systemic corticosteroid therapy within 4 weeks prior to randomization

Additional Information

Official title Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Genentech, Inc..