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OpenTrials
Completed

NCT Number: NCT00030966

Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis

The purpose of this study is to determine if natalizumab in combination with AVONEX 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 3

Primary location

Universitatsklinik fur Neurologie, Graz, Austria

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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 Avonex for at least the 12 months prior to randomization
  • Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization.
  • Cranial MRI scan demonstrating lesions consistent with MS.
  • Have given written informed consent to participate in the study.

Exclusion criteria

  • Primary progressive, secondary progressive, or progressive relapsing MS.
  • MS relapse has occurred within 50 days of randomization
  • A clinically significant infectious illness within 30 days prior to randomization
  • History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex for 116 weeks.
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
  • Unable to perform the Timed 25-Foot Walk, 9HPT and PASAT 3
  • Abnormal blood tests at Screening Visit

Treatment and study plan

Natalizumab

Drug

Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.

Other names: Tysabri

Placebo

Drug

Placebo monthly infusion for up to 116 weeks.

Primary outcomes

  1. Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS.

    Time frame: 1 year and 2 years

Secondary outcomes

  1. If this combination reduces MRI lesions and the overall rate of clinical relapses

    Time frame: 1 year and 2 years

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Collaborators

  • Elan Pharmaceuticals

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Feb 18, 2002
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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