Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis

Biogen110 enrolled

Overview

The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

110

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

NatalizumabDRUG

Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.

NatalizumabDRUG

Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.

PlaceboDRUG

Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of MS as defined by McDonald et al., criteria # 1-4 * Between the ages of 18 and 55, inclusive * Baseline EDSS score between 0.0 and 5.0, inclusive * Have been treated with GA for at least the 12 months prior to randomization Exclusion Criteria: * Primary progressive, secondary progressive or progressive relapsing MS * MS relapse has occurred within the 50 days prior to randomization * A clinically significant infectious illness * History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.

Outcomes

Primary Outcomes

Rate of development of new active lesions on MRI scans.

Time frame: Week 20

Secondary Outcomes

Incidence and severity of adverse events.

Time frame: Week 20

Data from ClinicalTrials.gov

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