Phase
Condition
Musculoskeletal Diseases
Dermatomyositis (Connective Tissue Disease)
Arthritis And Arthritic Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Met ACR criteria for diagnosis of active rheumatoid arthritis (RA) and have had atboth the Screening visit and Week 0 visit at least four swollen joints (out of 66assessed) and at least six tender joints(out of 68 assessed)
Subjects must have failed prior treatment with one or more disease-modifyingantirheumatic drugs (DMARDs)
DMARDs (other than methotrexate [MTX]) must have been discontinued for >= 28 days orat least 5 half-lives, whichever is greater, before the Week 0 visit
Traditional Chinese Medicines must have been discontinued for >= 28 days before theWeek 0 visit
Subjects must have received at least three months of treatment with MTX (minimum 7.5mg/week) and remained on a stable dose of MTX for >= 28 days prior to the Screeningvisit
Glucocorticoids equivalent to <= 10 mg of prednisone and prednisone equivalent musthave remained unchanged for at least 28 days prior to the Week 0 visit
Must have been able and willing to give written informed consent and to comply withthe requirements of this study protocol
Exclusion
Exclusion Criteria:
A history of, or current, acute inflammatory joint disease of different origin (e.g.,mixed connective tissue disease, seronegative spondyloarthropathy, psoriaticarthritis, Reiter's syndrome, systemic lupus erythematosus, fibromyalgia or anyarthritide with onset prior to age 16 years
Wheelchair-bound or bedridden
Joint surgery involving joints to be assessed within this study, within two monthsprior to the Screening visit
Intra-articular, intramuscular or intravenous administration of corticosteroids within 28 days prior to the Screening visit
Prior treatment with any TNF antagonist, including adalimumab
Subject considered by the investigator, for any reason, to be an unsuitable candidate
Female subject who is pregnant or breast-feeding or considering becoming pregnant
Study Design
Study Description
Connect with a study center
Site Reference ID/Investigator# 6259
Hefei, Anhui 230022
ChinaSite Not Available
Site Reference ID/Investigator# 6241
Beijing, 100853
ChinaSite Not Available
Site Reference ID/Investigator# 6266
Beijing, 100730
ChinaSite Not Available
Site Reference ID/Investigator# 6243
Guangzhou, 510260
ChinaSite Not Available
Site Reference ID/Investigator# 6247
Guangzhou, 510630
ChinaSite Not Available
Site Reference ID/Investigator# 6262
Harbin, 150001
ChinaSite Not Available
Site Reference ID/Investigator# 6248
Hepingjiebeikou, 100029
ChinaSite Not Available
Site Reference ID/Investigator# 6250
Shanghai, 200001
ChinaSite Not Available
Site Reference ID/Investigator# 6333
Shanghai, 200433
ChinaSite Not Available
Site Reference ID/Investigator# 6828
Shanghai, 200032
ChinaSite Not Available
Site Reference ID/Investigator# 6264
Xi'an, 710032
ChinaSite Not Available
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