Long-Term Assessment of Safety and Physical Function With AMG 108 in RA
A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis
1 other identifier
interventional
690
0 countries
N/A
Brief Summary
The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Sep 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2006
CompletedFirst Posted
Study publicly available on registry
August 29, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedDecember 13, 2016
December 1, 2016
1.8 years
August 24, 2006
December 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168
144 Weeks
Secondary Outcomes (1)
To determine whether long-term use of AMG 108 improves function in subjects with RA
144 Weeks
Study Arms (2)
1
EXPERIMENTAL350
2
EXPERIMENTAL350
Interventions
Eligibility Criteria
You may qualify if:
- Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll.
You may not qualify if:
- Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2006
First Posted
August 29, 2006
Study Start
September 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
December 13, 2016
Record last verified: 2016-12