Back to resultsLong-Term Assessment of Safety and Physical Function With AMG 108 in RA
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 108
AMG 108
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
350
350
Outcomes
Primary Outcome Measures
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168
Secondary Outcome Measures
To determine whether long-term use of AMG 108 improves function in subjects with RA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00369473
Brief Title
Long-Term Assessment of Safety and Physical Function With AMG 108 in RA
Official Title
A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
690 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
350
Arm Title
2
Arm Type
Experimental
Arm Description
350
Intervention Type
Drug
Intervention Name(s)
AMG 108
Intervention Description
125 mg via SC (subcutaneous) injection every 4 weeks
Intervention Type
Drug
Intervention Name(s)
AMG 108
Intervention Description
250 mg via SC (subcutaneous) injection every 4 weeks
Primary Outcome Measure Information:
Title
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168
Time Frame
144 Weeks
Secondary Outcome Measure Information:
Title
To determine whether long-term use of AMG 108 improves function in subjects with RA
Time Frame
144 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Long-Term Assessment of Safety and Physical Function With AMG 108 in RA
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