A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Placebo; Ocrelizumab; Avonex
Intervention description: Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.; Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.; Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
Intervention MeSH terms: Interferons; Interferon-beta; Ocrelizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        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