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

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ClinicalTrials.gov Identifier: NCT00097760
Recruitment Status : Completed
First Posted : December 1, 2004
Last Update Posted : June 18, 2009
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Natalizumab Drug: Placebo Phase 2

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)
Study Start Date : June 2003
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Rate of development of new active lesions on MRI scans. [ Time Frame: Week 20 ]

Secondary Outcome Measures :
  1. Incidence and severity of adverse events. [ Time Frame: Week 20 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097760


Sponsors and Collaborators
Biogen
Elan Pharmaceuticals
Investigators
Study Director: Biogen Idec, MD Biogen
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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

Responsible Party: Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT00097760     History of Changes
Other Study ID Numbers: C-1803
First Posted: December 1, 2004    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: June 2009

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
Natalizumab
Glatiramer Acetate
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents
Antirheumatic Agents