An open-label, multicenter extension study to evaluate the safety and tolerability of natalizumab in subjects with multiple sclerosis who have completed studies C-1801, C-1802, or C-1803.

• Conditions: Male and female subjects with multiple sclerosis who have completed natalizumab studies C-1801, C-1802, or C-1803

• Registration Number: EUCTR2004-000047-18-SE
• Lead Sponsor: Biogen Idec Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

Must give written informed concent.

Must be an MS subject who has completed studies C-1801, C-1802, or C-1803

C-1801 subjects must have completed all protocol-required evaluations (through the end of the study), and either remained on study drug for the entire study period or discontinued study drug after experiencing protocol-defined disease progression and chose treatment options specified in the protocol.

C-1802 subjects must have completed all protocol-required evaluations (through the end of the study), and either remained on study drug and/or AVONEX for the entire study period or discontinued study drug after experiencing protocol-defined disease progression and chose treatment options specified in the protocol.

C-1803 subjects must have completed all protocol-required evaluations (through the end of the study) and remained on the study drug for the entire study period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of, or available abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermantologic, psychiatric (including major depression), renal, and/or other major disease, that would preclude the administration of natalizumab for 24 months.

History of malignancy.

Histroy of severe allergic or anaphylactic reactions or known drug hypersensitivity.

A significant change (as determined by the Investigator) in the subject's medical history from their previous natalizumab study.

A clinically significant infectious illness within 30 days prior to study entry visit in study C-1808.

C-1802 subjects who have discontinued both study drug and AVONEX.

Any subjects who have discontinued study drug in study C-1801, C-1802, or C-1803 because of an AE or due to reasons other than significant disease progression.

Female subjects who are not post menopausal for at least 1 year, surgically sterile or willing to practice effective contraception during the study.
Women who are breast feeding, pregnant or planning to become pregnant while on the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified