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Open-Label Natalizumab Safety Extension Study

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: NCT00276172
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : June 22, 2009
Sponsor:
Information provided by:
Biogen

Tracking Information
First Submitted Date  ICMJE January 11, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date June 22, 2009
Study Start Date  ICMJE December 2003
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2009)
The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed. [ Time Frame: Month 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed.
Change History Complete list of historical versions of study NCT00276172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2009)
EDSS scores and assessments of relapse. [ Time Frame: Month 24 ]
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 Open-Label Natalizumab Safety Extension Study
Official Title  ICMJE An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803
Brief Summary The primary objective of this study is to determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: Natalizumab
Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months
Other Name: Tysabri
Study Arms  ICMJE Experimental: Natalizumab
Open-label natalizumab
Intervention: Drug: Natalizumab
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 19, 2009)
1615
Original Enrollment  ICMJE
 (submitted: January 12, 2006)
1900
Actual Study Completion Date  ICMJE January 2006
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must give written informed consent.
  • Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803

Exclusion Criteria:

  • History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment.
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity
  • A clinically significant infectious illness within 30 days prior to study entry.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276172
Other Study ID Numbers  ICMJE C-1808
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen Idec MD, Biogen Idec
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Panzara, MD, MPH Biogen
Principal Investigator: Paul O'Connor, MD St. Michael's Hospital, Toronto
Study Chair: Eve Versage Biogen Idec. Contact for more details
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