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

  • Autoimmune Disorder
  • Multiple Sclerosis (MS)
  • Relapsing-Remitting Multiple Sclerosis (RRMS)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Countries
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Mexico
  • Romania
  • Russian Federation
  • Serbia
  • Slovakia
  • Spain
  • Switzerland
  • Ukraine
  • United Kingdom
  • United States
Study Identifier:

NCT00676715 2007-006338-32 WA21493 ACT4422g

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study 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 participants with Relapsing Remitting Multiple Sclerosis (RRMS).

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT00676715, ACT4422g, 2007-006338-32,WA21493 Study Identifier
      Placebo, Ocrelizumab, Avonex Treatments
      Multiple Sclerosis, Relapsing-Remitting Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 55 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
      • Relapsing-remitting multiple sclerosis (MS)
      • Ages 18-55 years inclusive
      • For sexually active female and male participants 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 IV 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 IV 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, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
      • Systemic corticosteroid therapy within 4 weeks prior to randomization

      For the latest version of this information please go to www.forpatients.roche.com

       

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