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| Sponsor: | Genentech |
|---|---|
| Collaborator: |
Hoffmann-La Roche |
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00676715 |
Purpose
This is a 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: interferon beta-1a Drug: methylprednisolone Drug: ocrelizumab Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| 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 |
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: methylprednisolone
IV repeating dose
Drug: ocrelizumab
IV repeating dose
|
| 2: Experimental |
Drug: methylprednisolone
IV repeating dose
Drug: ocrelizumab
IV repeating dose
|
| 3: Placebo Comparator |
Drug: methylprednisolone
IV repeating dose
Drug: placebo
Intravenous repeating dose
|
| 4: Active Comparator |
Drug: interferon beta-1a
Intramuscular repeating dose
Drug: methylprednisolone
IV repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Genentech Trial Information Support Line | 888-662-6728 |
| United States, Arizona | |
| Phoenix Neurological Associates, Ltd. | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact: Nicole Hank 602-258-3354 ext 137 nhank@pnal.net | |
| United States, Florida | |
| MS Center of Vero Beach | Recruiting |
| Vero Beach, Florida, United States, 32960 | |
| Contact: Victoria Bussey 772-299-4304 vbussey@geodysseyrsch.com | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Kelly Dickerson 913-588-0080 kdickerson@kumc.edu | |
| United States, Michigan | |
| Michigan Institute for Neurological Disorders | Recruiting |
| Farmington Hills, Michigan, United States, 48334 | |
| Contact: Sonda Rossman 248-553-0010 SondaLL@aol.com | |
| United States, New York | |
| Island Neurological Associates, P.C. | Recruiting |
| Plainview, New York, United States, 11803 | |
| Contact: Tiffany Harding 516-822-2230 tiffanyharding@aol.com | |
| United States, Ohio | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43221 | |
| Contact: Cindy Overholts 614-366-3526 cindy.overholts@osumc.edu | |
| United States, Texas | |
| Integra Clinical Research | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Andrea Olivas 210-614-4884 andrea@integraclinicalresearch.com | |
| Study Director: | Donna Masterman, M.D. | Genentech |
More Information
| Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
| Study ID Numbers: | ACT4422g, WA21493 |
| Study First Received: | May 9, 2008 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00676715 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
RRMS MS Avonex |
|
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Multiple Sclerosis Therapeutic Uses |
Interferon beta 1a Autoimmune Diseases of the Nervous System Methylprednisolone Hemisuccinate Autoimmune Diseases Antineoplastic Agents, Hormonal Immune System Diseases Demyelinating Diseases Interferons Nervous System Diseases Adjuvants, Immunologic Gastrointestinal Agents Interferon-beta Methylprednisolone acetate Sclerosis Glucocorticoids |