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

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen
ClinicalTrials.gov Identifier:
NCT00030966
First received: February 15, 2002
Last updated: June 17, 2009
Last verified: June 2009
  Purpose
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).

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Natalizumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • If this combination reduces MRI lesions and the overall rate of clinical relapses [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]

Enrollment: 1200
Study Start Date: January 2002
Study Completion Date: December 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
Drug: Natalizumab
Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
Other Name: Tysabri
Placebo Comparator: Group 2
Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
Drug: Placebo
Placebo monthly infusion for up to 116 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030966

  Show 88 Study Locations
Sponsors and Collaborators
Biogen
Elan Pharmaceuticals
Investigators
Study Director: Michael Panzara, MD, MPH Biogen
Principal Investigator: Richard A Rudick, MD The Cleveland Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00030966     History of Changes
Other Study ID Numbers: C-1802 
Study First Received: February 15, 2002
Last Updated: June 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen:
Multiple Sclerosis
MS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Natalizumab
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 25, 2016