Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)
Peripheral Spondyloarthritis
About this trial
This is an interventional treatment trial for Peripheral Spondyloarthritis focused on measuring peripheral spondyloarthritis, adalimumab, humira
Eligibility Criteria
Inclusion Criteria:
- Adult participants who had inadequate response to >= 2 non-steroidal anti-inflammatories (NSAIDs)
- Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria
- Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit were Negative
- Ability to administer subcutaneous injections
- General good health
Exclusion Criteria:
- Prior anti-tumor necrosis factor (TNF) therapy
- Psoriasis or Psoriatic Arthritis
- Fulfillment of modified New York criteria for Ankylosing Spondylitis
- Recent infection requiring treatment
- Significant medical events or conditions that had put patients at risk for participation
- Female participants who were pregnant or breast-feeding or considering becoming pregnant during the study
- History of cancer, except successfully treated skin cancer
- Recent history of drug or alcohol abuse
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Double-blind (DB) Adalimumab
Double-blind Placebo
Double-blind Adalimumab / Open-label Adalimumab
Double-blind Placebo / Open-label Adalimumab
Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.