Natalizumab (Tysabri) Re-Initiation of Dosing. (STRATA)
This study has been terminated.
Sponsor:
Biogen Idec
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00297232
First received: February 27, 2006
Last updated: December 18, 2014
Last verified: December 2014
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Natalizumab
U.S. FDA Resources
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00297232
Show 111 Study Locations
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: | December 18, 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:
|
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System |
Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on February 26, 2015