Phase 2
N=218
A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Bottom Line
View on ClinicalTrials.gov: NCT00676715 ↗Enrolled (actual)
218
Serious AEs
27.4%
Results posted
May 2017
Primary outcome: Primary: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain — 5.6; 0.6; 0.2; 6.9 lesions — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Ocrelizumab (Drug); Avonex (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain |
5.6; 0.6; 0.2; 6.9 | <0.0001 sig |
| SECONDARY Annualized Protocol Defined Relapse Rate at Week 24 |
0.557; 0.127; 0.213; 0.364 | 0.0019 sig |
| SECONDARY Percentage of Participants Who Remained Relapse Free at Week 24 |
75.9; 85.5; 87.3; 77.8 | 0.1978 |
| SECONDARY Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24 |
8950.84; 13972.61; 13178.30; 13209.11; -112.31; -878.84 | 0.1391 |
| SECONDARY Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain |
5.1; 0.8; 0.8; 6.2 | <0.0001 sig |
| SECONDARY Total Number of Gadolinium-Enhancing T1 Lesions |
8.7; 2.5; 1.8; 10.3 | 0.0004 sig |
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
Data sourced from ClinicalTrials.gov (NCT00676715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.