A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: natalizumab

• Registration Number: NCT00831649
• Lead Sponsor: Biogen

Brief Summary

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of natalizumab in subjects with active rheumatoid arthritis (RA) receiving concomitant methotrexate (MTX)

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2005-02
• Status Verified: 2009-01
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-29
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
natalizumab	natalizumab	-

Primary Outcome Measures

Name	Time	Method
The number and proportion of subjects with SAEs
The number and proportion of subjects with AEs
The number and percentage of subjects who discontinue early from the study due to an AE
Assessment of clinical laboratory parameters, physical examination, and vital signs.