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

Biogen

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Placebo; Drug: Natalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097760

C-1803

Details and patient eligibility

About

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).

Enrollment: 110 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Description:

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

Treatment:

Drug: Natalizumab

Drug: Natalizumab

Group 2

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo