Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 53 of 120 for:    COP1

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

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.
 
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

Tracking Information
First Submitted Date  ICMJE November 30, 2004
First Posted Date  ICMJE December 1, 2004
Last Update Posted Date June 18, 2009
Study Start Date  ICMJE June 2003
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2009)
Rate of development of new active lesions on MRI scans. [ Time Frame: Week 20 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00097760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2009)
Incidence and severity of adverse events. [ Time Frame: Week 20 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
Official Title  ICMJE Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2009)
110
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2004
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00097760
Other Study ID Numbers  ICMJE C-1803
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen Idec MD, Biogen Idec, Inc.
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Elan Pharmaceuticals
Investigators  ICMJE
Study Director: Biogen Idec, MD Biogen
PRS Account Biogen
Verification Date June 2009

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