Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis

The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open label (OL) safety and efficacy assessments in participants with non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral spondyloarthritis (SpA) who have had an inadequate response to >= 2 non-steroidal anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for, NSAIDs.

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