A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis - Full Text View

Sponsor:	Genentech
Collaborator:	Roche Pharma AG
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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Interferon beta Interferon-beta Medrol veriderm Methylprednisolone Interferon beta 1a Ocrelizumab Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone Interferons

U.S. FDA Resources

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
Experimental: 1	Drug: methylprednisolone IV repeating dose Drug: ocrelizumab IV repeating dose
Experimental: 2	Drug: methylprednisolone IV repeating dose Drug: ocrelizumab IV repeating dose
Placebo Comparator: 3	Drug: methylprednisolone IV repeating dose Drug: placebo Intravenous repeating dose
Active Comparator: 4	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

Sponsors and Collaborators

Genentech

Roche Pharma AG

Investigators

Study Director:

Donna Masterman, M.D.

Genentech

More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. Epub 2011 Oct 31.

Responsible Party:	Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00676715 History of Changes
Other Study ID Numbers:	ACT4422g, WA21493
Study First Received:	May 9, 2008
Last Updated:	November 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

RRMS
MS
Avonex

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta 1a
Methylprednisolone Hemisuccinate
Prednisolone

Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone phosphate
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012