Rheumatoid Arthritis
Conditions
Keywords
ACR criteria, methotrexate, DMARDs, patient reported outcomes, joint assessment
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.
Interventions
DRUGAMG 108
50mg via SC (subcutaneous) injection every 4 weeks
DRUGPlacebo
Placebo via SC (subcutaneous) injection every 4 weeks
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 response | 24 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed