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Natalizumab (Tysabri) Re-Initiation of Dosing. (STRATA)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00297232
First received: February 27, 2006
Last updated: August 27, 2014
Last verified: August 2014

February 27, 2006
August 27, 2014
March 2006
April 2014   (final data collection date for primary outcome measure)
  • Number of participants with development of antibodies to natalizumab during the Initial Treatment Period [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events/serious adverse events during the Initial Treatment Period [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Change in Expanded Disability Status Scale (EDSS) scores over time [ Time Frame: Up to 10 years post initial treatment ] [ Designated as safety issue: No ]
  • incidence of development of antibodies to natalizumab
  • incidence of adverse events
Complete list of historical versions of study NCT00297232 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Natalizumab (Tysabri) Re-Initiation of Dosing.
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

The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN) , glatiramer acetate (GA), or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the Long-Term Treatment Period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by expanded disability status scale (EDSS) changes over time.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
Drug: Natalizumab
Administered as specified in the treatment arm
Other Name: Tysabri (BG00002)
Experimental: Natalizumab
300 mg intravenous(IV) infusions once every 4 weeks for up to 480 weeks
Intervention: Drug: Natalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
716
April 2014
April 2014   (final data collection date for primary outcome measure)

Key Inclusion Criteria

  • Multiple Sclerosis (MS) subjects who completed Study C-1801 (NCT00027300) or C-1802 (NCT00030966) and a Dosing Suspension Safety Evaluation (neurological examination and a magnetic resonance imaging [MRI] scan) or participated in the IMA 04001 (STARS) Study
  • Subjects 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 (NCT00306592) in Canada will be allowed to enter this study at the start of the long-term treatment period (Week 52 - 480).

Key Exclusion Criteria

  • Considered by the Investigator to be immunocompromised
  • History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
  • History of any major disease or malignancy
  • Discontinued natalizumab in a previous study due to allergic reaction

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Netherlands,   New Zealand,   Poland,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT00297232
101-MS-321
No
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
August 2014

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