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
  Purpose

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.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
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:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Enrollment: 716
Study Start Date: March 2006
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Natalizumab
300 mg intravenous(IV) infusions once every 4 weeks for up to 480 weeks
Drug: Natalizumab
Administered as specified in the treatment arm
Other Name: Tysabri (BG00002)

  Eligibility

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 111 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00297232     History of Changes
Other Study ID Numbers: 101-MS-321
Study First Received: February 27, 2006
Last Updated: August 27, 2014
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)
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
Israel: Ethics Commission
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Finland: Finnish Medicines Agency
Turkey: Ministry of Health
Germany: Paul-Ehrlich-Institut

Keywords provided by Biogen Idec:
Multiple Sclerosis
MS

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

ClinicalTrials.gov processed this record on September 18, 2014