A Study of the Efficacy and Safety of Ocrelizumab in Patients With Rel

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

CompletedPhase 2Relapsing MSNCT006767152007-006338-32

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain <0.0001
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain <0.0001
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain 0.7496

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Compared with

Placebo

  • Placebo

Results by group

Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain

Week 12 to Week 24

GroupValueIntervalNumber analysed
Placebo / Ocrelizumab 600 mg5.6 lesions12.53 (Standard Deviation)54
Ocrelizumab 600 mg / Ocrelizumab 600 mg0.6 lesions1.52 (Standard Deviation)51
Ocrelizumab 1000 mg/ Ocrelizumab 600 mg0.2 lesions0.65 (Standard Deviation)52
Avonex / Ocrelizumab 600 mg6.9 lesions16.01 (Standard Deviation)52

Placebo / Ocrelizumab 600 mg

5.6

Ocrelizumab 600 mg / Ocrelizumab 600 mg

0.6

Ocrelizumab 1000 mg/ Ocrelizumab 600 mg

0.2

Avonex / Ocrelizumab 600 mg

6.9

p = <0.0001

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo/Ocrelizumab 600mg5411 (20.4%)3
Ocrelizumab 600mg/Ocrelizumab 600mg5517 (30.9%)1
Ocrelizumab 1000mg/Ocrelizumab 600mg5516 (29.1%)3
Avonex/Ocrelizumab 600 mg5416 (29.6%)2
Ocrelizumab 600 mg Open Label Extension (OLE)10328 (27.2%)6

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain

    Week 12 to Week 24

    MRI lesions

  • To investigate the effect of ocrelizumab given as two dose regimens of 600 or 1000 mg intravenously on the total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at weeks 12, 16, 20 and 24 as compared to placebo.

    MRI lesions

Other measures (5)

  • Annualized Protocol Defined Relapse Rate at Week 24

    Week 24

    Relapses

  • Percentage of Participants Who Remained Relapse Free at Week 24

    Week 24

    Relapses

  • Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24

    Baseline, Week 24

    MRI lesions

  • Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain

    Weeks 4 to Week 24

    MRI lesions

  • Total Number of Gadolinium-Enhancing T1 Lesions

    Weeks 4 to Week 24

    MRI lesions

Who could take part

Relapsing MS · 18 to 55

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Jul 2008

    2. Main results due

      Mar 2012

    3. Finished

      Nov 2023

    4. Results posted

      May 2017

    Assembled by software from public sources.