Rheumatoid Arthritis
Conditions
Brief summary
A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate
Interventions
BIOLOGICALadalimumab
40 mg adalimumab sc, every other week
BIOLOGICALplacebo
placebo sc, every other week
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits 6 swollen joints and 9 tender joints.
Exclusion criteria
* A history of, or current, acute inflammatory joint disease of different origin than RA (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age 16 years).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| ACR50 | Week 12 |
| ACR70 | Week 12 |
Countries
Taiwan
Outcome results
None listed