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Natalizumab (Tysabri) Re-Initiation of Dosing

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis

Intervention: Natalizumab (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Summary

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 reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, 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.

Clinical Details

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, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression

Time to 48-week Confirmed EDSS Progression

Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0

Detailed description: Study 101-MS-322 (NCT00306592) was conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab in former clinical trial participants in Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760) and included subjects in North America. In parallel with the conduct of that study, this study (101-MS-321 [NCT00297232]) was initiated for participants in Europe and the rest of the world. In addition, after 48 weeks, participants from 101-MS-322 (NCT00306592) could enter study 101-MS-321 (NCT 00297232), which was considered the Long-Term Treatment Period of 101-MS-322 (NCT00306592). The primary purpose and primary outcome for both studies are identical; therefore, the combined long-term data from both studies are presented. (Combined Week 48 data from both studies are presented in the 101-MS-322 [NCT00306592] record.)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Key Inclusion Criteria

- MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803

(NCT00097760) and a Dosing Suspension Safety Evaluation (neurological examination or a magnetic resonance imaging 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 and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-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.

Locations and Contacts

Research Site, Camperdown 2050, Australia

Research Site, Heidelberg 3084, Australia

Research Site, Parkville 3050, Australia

Research Site, Brugge 8000, Belgium

Research Site, Brussels 1070, Belgium

Research Site, Charleroi 6000, Belgium

Research Site, Diepenbeek 3590, Belgium

Research Site, Melsbroek 1820, Belgium

Research Site, Sijsele 8340, Belgium

Research Site, Brno 625 00, Czech Republic

Research Site, Brno 656 91, Czech Republic

Research Site, Hradec Kralove 500 05, Czech Republic

Research Site, Olomouc 775 20, Czech Republic

Research Site, Ostrava 708 52, Czech Republic

Research Site, Pardubice 532 03, Czech Republic

Research Site, Plzen 323 00, Czech Republic

Research Site, Praha 2 12000, Czech Republic

Research Site, Praha 5 150 06, Czech Republic

Research Site, Aarhus C 8000, Denmark

Research Site, Esbjerg 6700, Denmark

Research Site, Kobenhavn 2100, Denmark

Research Site, Helsinki 00290, Finland

Research Site, Tampere 33520, Finland

Research Site, Turku 20100, Finland

Research Site, Besancon 25030, France

Research Site, Bordeaux 33076, France

Research Site, Clermont-Ferrand 63003, France

Research Site, Creteil 94101, France

Research Site, Dijon 21033, France

Research Site, Lille 59037, France

Research Site, Lyon 69677, France

Research Site, Marseille 13385, France

Research Site, Nancy 54035, France

Research Site, Paris 75019, France

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Research Site, Rennes 35033, France

Research Site, Strasbourg 67091, France

Research Site, Toulouse 31059, France

Research Site, Berlin 13347, Germany

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Research Site, Auckland 1023, New Zealand

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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.

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.

Starting date: March 2006
Last updated: May 8, 2015

Page last updated: August 23, 2015

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