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A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
This study is currently recruiting participants.
Verified by Genentech, August 2008
First Received: May 9, 2008   Last Updated: August 22, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain [ Time Frame: Weeks 12, 16, 20 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The annualized protocol defined relapse rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients who remain relapse-free [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in total volume of T2 lesions on MRI scans of the brain [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

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
Criteria

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 β 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676715

Contacts
Contact: Genentech Trial Information Support Line 888-662-6728

Locations
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    
Sponsors and Collaborators
Genentech
Hoffmann-La Roche
Investigators
Study Director: Donna Masterman, M.D. Genentech
  More Information

No publications provided

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

Keywords provided by Genentech:
RRMS
MS
Avonex

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010