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

NCT00097760 | Completed Phase 2 DMC

• 1 other identifier: C-1803
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; MS

Outcome Measures

Primary Outcomes (1)

• Rate of development of new active lesions on MRI scans.

  Week 20

Secondary Outcomes (1)

• Incidence and severity of adverse events.

  Week 20

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Natalizumab

Group 2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Natalizumab DRUG

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

Also known as: Tysabri

Group 1

Placebo DRUG

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

Group 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead
• Elan Pharmaceuticals: collaborator

Related Links

• The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.
• MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen.

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Biogen Idec, MD

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 30, 2004
• First Posted: December 1, 2004
• Study Start: June 1, 2003
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: June 18, 2009

Record last verified: 2009-06