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

Tracking Information
First Received Date ^ICMJE	February 27, 2006
Last Updated Date	June 7, 2012
Start Date ^ICMJE	March 2006
Estimated Primary Completion Date	May 2017 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 25, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: February 27, 2006)	incidence of development of antibodies to natalizumab incidence of adverse events
Change History	Complete list of historical versions of study NCT00297232 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 25, 2011)	frequency of relapses [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Natalizumab Re-Initiation of Dosing.
Official Title ^ICMJE	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
Brief Summary	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).
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).
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Multiple Sclerosis, Relapsing-Remitting
Intervention ^ICMJE	Drug: natalizumab 300 mg IV every 4 weeks for up to 480 weeks Other Name: Tysabri
Study Arm (s)	Experimental: 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	Active, not recruiting
Enrollment ^ICMJE	716
Estimated Completion Date	November 2017
Estimated Primary Completion Date	May 2017 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland, Turkey, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00297232
Other Study ID Numbers ^ICMJE	101-MS-321
Has Data Monitoring Committee	No
Responsible Party	Biogen Idec MD, Biogen Idec, Inc.
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Elan Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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