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OpenTrials
Completed

NCT Number: NCT00097760

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

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).

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Tysabri

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.

Primary outcomes

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

    Time frame: Week 20

Secondary outcomes

  1. Incidence and severity of adverse events.

    Time frame: Week 20

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Collaborators

  • Elan Pharmaceuticals

Registry information

Official study title

Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 1, 2004
Registry last updated
Jun 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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