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Natalizumab Re-Initiation of Dosing. (STRATA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00297232
First received: February 27, 2006
Last updated: June 7, 2012
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study it to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab (during the first 48 weeks) and assess the long-term efficacy and safety of natalizumab (for an additional 432 weeks).


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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 or C-1802 and a Dosing Suspension Safety Evaluation

Resource links provided by NLM:

Drug Information available for: Natalizumab
U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • EDSS scores [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • incidence of development of antibodies to natalizumab [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • incidence of adverse events/serious adverse events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • frequency of relapses [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 716
Study Start Date: March 2006
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: natalizumab Drug: natalizumab
300 mg IV every 4 weeks for up to 480 weeks
Other Name: Tysabri

Detailed Description:

This is a multicenter, open label, single-arm, long-term treatment study. Natalizumab will be administered as a 300 mg intravenous (IV) infusion once every 4 weeks for up to 480 weeks (10 years).

  Eligibility

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

MS subjects who completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation (neurological examination and an MRI scan)or participated in the IMA 04001 (STARS) Study who are considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (PML) and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon-beta and glatiramer acetate) while being treated with natalizumab during the study. In addition, subjects who completed 48 weeks of treatment in Study 101-MS-322 in Canada will be allowed to enter this study at the start of the long-term treatment period (Week 52 - 480). Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297232

  Show 40 Study Locations
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
  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 Idec.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT00297232     History of Changes
Other Study ID Numbers: 101-MS-321
Study First Received: February 27, 2006
Last Updated: June 7, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Italy: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency
Israel: Ethics Commission
Switzerland: Swissmedic
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Ireland: Irish Medicines Board
Australia: Department of Health and Ageing Therapeutic Goods Administration
Spain: Spanish Agency of Medicines
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Greece: National Organization of Medicines
Sweden: Medical Products Agency
Hungary: National Institute of Pharmacy
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Turkey: Ministry of Health
Germany: Paul-Ehrlich-Institut

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 May 19, 2013