Natalizumab Re-Initiation of Dosing

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00306592
First received: January 31, 2006
Last updated: December 20, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to evaluate the safety of natalizumab (TYSABRI®) monotherapy following re-exposure to natalizumab. This includes assessing the risk of hypersensitivity, immunogenicity, and infection, and confirming the safety of switching from interferon-beta, glatiramer acetate, or other multiple sclerosis therapies to natalizumab.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Natalizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety Evaluation

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Number of Subjects With Adverse Events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Hypersensitivity-Related Adverse Events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Persistent Antibodies to Natalizumab [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 404
Study Start Date: March 2006
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Natalizumab
Open Label 300 mg IV Natalizumab
Drug: Natalizumab
300 mg IV monthly for up to 48 weeks
Other Name: Tysabri

Detailed Description:

Study 101-MS-322 (NCT00306592) was conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab of former clinical trial patients in Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760). This study included patients in North America. In parallel with the conduct of this study, a similar study, 101-MS-321 (NCT 00297232) was initiated for patients in Europe and the rest of the world. The primary purpose and primary outcome for both studies were identical, therefore, the combined data from both studies are presented.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MS subjects who completed Study C-1801, C-1802, or C-1803 and completed a Dosing Suspension Safety Evaluation (neurological examination and MRI scan)
  • Considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 [NCT000276172] may be used)
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment
  • History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306592

  Show 61 Study Locations
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
Investigators
Study Director: Medical Director Biogen Idec
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT00306592     History of Changes
Other Study ID Numbers: 101-MS-322
Study First Received: January 31, 2006
Results First Received: June 30, 2009
Last Updated: December 20, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Biogen Idec:
Multiple Sclerosis
MS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 21, 2014