Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00647920
• Date of registration: 28/03/2008
• Prospective Registration: No
• Primary sponsor: Abbott
• Public title: Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate
• Scientific title: Study of the Human Anti-TNF-Antibody Adalimumab
• Date of first enrolment: July 2003
• Target sample size: 47
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00647920
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Taiwan

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: adalimumab

Biological: placebo

Primary Outcome(s)

ACR20 [Time Frame: Week 12]

Secondary Outcome(s)

ACR50 [Time Frame: Week 12]

ACR70 [Time Frame: Week 12]

Secondary ID(s)

M02-573

Source(s) of Monetary Support

Please refer to primary and secondary sponsors