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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00676715
First received: May 9, 2008
Last updated: September 2, 2014
Last verified: September 2014

May 9, 2008
September 2, 2014
January 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00676715 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
  • Drug: ocrelizumab
    IV repeating dose
  • Drug: placebo
    Intravenous repeating dose
  • Drug: methylprednisolone
    IV repeating dose
  • Drug: interferon beta-1a
    Intramuscular repeating dose
  • Experimental: 1
    Interventions:
    • Drug: ocrelizumab
    • Drug: methylprednisolone
  • Experimental: 2
    Interventions:
    • Drug: ocrelizumab
    • Drug: methylprednisolone
  • Placebo Comparator: 3
    Interventions:
    • Drug: placebo
    • Drug: methylprednisolone
  • Active Comparator: 4
    Interventions:
    • Drug: methylprednisolone
    • Drug: interferon beta-1a
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. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
Not Provided
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Bulgaria,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Italy,   Mexico,   Netherlands,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Switzerland,   Ukraine,   United Kingdom
 
NCT00676715
ACT4422g, 2007-006338-32, WA21493
Not Provided
Genentech
Genentech
Roche Pharma AG
Study Director: Clinical Trials Genentech
Genentech
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP