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

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00097760
First received: November 30, 2004
Last updated: June 17, 2009
Last verified: June 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
 Drug: Natalizumab
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Rate of development of new active lesions on MRI scans. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of adverse events. [ Time Frame: Week 20 ] [ Designated as safety issue: Yes ]
Enrollment: 110
Study Start Date: June 2003
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
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
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
Other Name: Tysabri
Drug: Natalizumab
Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.
Other Name: Tysabri
Placebo Comparator: Group 2
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
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Other Name: Placebo

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
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 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.
  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: NCT00097760

Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
Investigators
Study Director: Biogen Idec, MD Biogen Idec
  More Information

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

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT00097760     History of Changes
Other Study ID Numbers: C-1803
Study First Received: November 30, 2004
Last Updated: June 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Multiple Sclerosis
MS

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
 Nervous System Diseases
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015