Long-Term Assessment of Safety and Physical Function With AMG 108 in RA

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: AMG 108

• Registration Number: NCT00369473
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-24
• Study First Submitted QC: 2006-08-24
• Study First Posted: 2006-08-29
• Study Start: 2006-09
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2016-12
• Disposition First Submitted: 2016-12-09
• Disposition First Submitted QC: 2016-12-09
• Last Update Submitted: 2016-12-09
• Disposition First Posted: 2016-12-13
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 690

Inclusion Criteria

• Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll.

Exclusion Criteria

• Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	AMG 108	350
1	AMG 108	350

Primary Outcome Measures

Name	Time	Method
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168	144 Weeks

Secondary Outcome Measures

Name	Time	Method
To determine whether long-term use of AMG 108 improves function in subjects with RA	144 Weeks