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NCT00369473 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

Official title:
A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00369473
Other study ID # 20060119
Secondary ID
Status Completed
Phase Phase 2
First received August 24, 2006
Last updated December 9, 2016
Start date September 2006
Est. completion date June 2008

Study information
Verified date December 2016
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 690
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AMG 108
125 mg via SC (subcutaneous) injection every 4 weeks
• AMG 108
250 mg via SC (subcutaneous) injection every 4 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Outcome
Type Measure Description Time frame Safety issue
Primary To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168 144 Weeks Yes
Secondary To determine whether long-term use of AMG 108 improves function in subjects with RA 144 Weeks No
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