Back to resultsA Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 108
AMG 108
AMG 108
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring ACR criteria, methotrexate, DMARDs, patient reported outcomes, joint assessment
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
3
2
4
Arm Description
196 subjects
196 subjects
196 subjects
196 subjects
Outcomes
Primary Outcome Measures
ACR20 response
Secondary Outcome Measures
Change in subject reported outcomes
ACRn, AUC ACRn, ACR50, ACR70, and DAS28
PK parameters
Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00293826
Brief Title
A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
ACR criteria, methotrexate, DMARDs, patient reported outcomes, joint assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
813 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
196 subjects
Arm Title
3
Arm Type
Experimental
Arm Description
196 subjects
Arm Title
2
Arm Type
Experimental
Arm Description
196 subjects
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
196 subjects
Intervention Type
Drug
Intervention Name(s)
AMG 108
Intervention Description
50mg via SC (subcutaneous) injection every 4 weeks
Intervention Type
Drug
Intervention Name(s)
AMG 108
Intervention Description
250mg via SC (subcutaneous) injection every 4 weeks
Intervention Type
Drug
Intervention Name(s)
AMG 108
Intervention Description
125mg via SC (subcutaneous) injection every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo via SC (subcutaneous) injection every 4 weeks
Primary Outcome Measure Information:
Title
ACR20 response
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Change in subject reported outcomes
Time Frame
24 Weeks
Title
ACRn, AUC ACRn, ACR50, ACR70, and DAS28
Time Frame
24 Weeks
Title
PK parameters
Time Frame
24 Weeks
Title
Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status
Time Frame
24 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20950476
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
Learn more about this trial
A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis
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