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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097760
First Posted: December 1, 2004
Last Update Posted: June 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen
November 30, 2004
December 1, 2004
June 18, 2009
June 2003
March 2004   (Final data collection date for primary outcome measure)
Rate of development of new active lesions on MRI scans. [ Time Frame: Week 20 ]
Not Provided
Complete list of historical versions of study NCT00097760 on ClinicalTrials.gov Archive Site
Incidence and severity of adverse events. [ Time Frame: Week 20 ]
Not Provided
Not Provided
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Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
  • 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
  • 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.
  • 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.
    Interventions:
    • Drug: Natalizumab
    • Drug: Natalizumab
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
March 2004
March 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00097760
C-1803
Yes
Not Provided
Not Provided
Biogen Idec MD, Biogen Idec, Inc.
Biogen
Elan Pharmaceuticals
Study Director: Biogen Idec, MD Biogen
Biogen
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP