Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

Study Identifier
M10-883
CT.gov Identifier
NCT01064856
EudraCT Identifier
2009-014567-39
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
    • Study Drug
  • Adalimumab
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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

    Protocol Summary

    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.

    Study Locations

    No locations found.