A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.
1 other identifier
interventional
813
0 countries
N/A
Brief Summary
The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.
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 Mar 2006
Typical duration for phase_2 rheumatoid-arthritis
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
February 17, 2006
CompletedFirst Posted
Study publicly available on registry
February 20, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedMarch 5, 2010
March 1, 2010
1.7 years
February 17, 2006
March 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR20 response
24 Weeks
Secondary Outcomes (4)
Change in subject reported outcomes
24 Weeks
ACRn, AUC ACRn, ACR50, ACR70, and DAS28
24 Weeks
PK parameters
24 Weeks
Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status
24 Weeks
Study Arms (4)
1
EXPERIMENTAL196 subjects
3
EXPERIMENTAL196 subjects
2
EXPERIMENTAL196 subjects
4
PLACEBO COMPARATOR196 subjects
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
- Must be taking MTX consecutively for \>/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening
You may not qualify if:
- Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
- Presence of serious infection
- Class IV rheumatoid arthritis
- Prior or current history of tuberculosis infection or exposure
- Any other DMARDs other than methotrexate within 6 weeks of screening
- Pregnant or nursing
- Receipt of live vaccines within 3 months
- Felty's syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Cardiel MH, Tak PP, Bensen W, Burch FX, Forejtova S, Badurski JE, Kakkar T, Bevirt T, Ni L, McCroskery E, Jahreis A, Zack DJ. A phase 2 randomized, double-blind study of AMG 108, a fully human monoclonal antibody to IL-1R, in patients with rheumatoid arthritis. Arthritis Res Ther. 2010;12(5):R192. doi: 10.1186/ar3163. Epub 2010 Oct 15.
PMID: 20950476DERIVED
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
Study Record Dates
First Submitted
February 17, 2006
First Posted
February 20, 2006
Study Start
March 1, 2006
Primary Completion
November 1, 2007
Study Completion
February 1, 2008
Last Updated
March 5, 2010
Record last verified: 2010-03