Rheumatoid Arthritis Clinical Trial
Official title:
Study of the Human Anti-TNF-Antibody Adalimumab
NCT number | NCT00647920 |
Other study ID # | M02-573 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | March 28, 2008 |
Last updated | March 28, 2008 |
Start date | July 2003 |
Verified date | March 2008 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate
Status | Completed |
Enrollment | 47 |
Est. completion date | |
Est. primary completion date | April 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ACR20 | Week 12 | No | |
Secondary | ACR50 | Week 12 | No | |
Secondary | ACR70 | Week 12 | No |
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