Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Intervention: adalimumab; Placebo
Intervention description: 40 mg every other week; every other week
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 673.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Spondylitis; Spondylarthropathy; Ankylosing Spondyloarthritis; Spondyloarthritis; Spinal Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Adalimumab; Antirheumatic Agents; Anti-Inflammatory Agents

Summary:

      The objective of this multicenter, randomized, double-blind study was to evaluate the
      efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given
      every other week SC in maintaining remission in subjects with moderate to severe
      non-radiographic axial spondyloarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants with inadequate response to ≥2 nonsteroidal anti-inflammatory drugs
             (NSAIDs)

          -  Participants with non-radiographic axial spondyloarthritis fulfilling the Assessment
             of Spondyloarthritis International Society (ASAS) axial SpA classification criteria,
             but not fulfilling the radiologic criterion of the modified New York criteria for
             ankylosing spondylitis

          -  Participants must have baseline disease activity as defined by having an Ankylosing
             Spondylitis Disease Activity Score (ASDAS) ≥ 2.100, Bath Ankylosing Spondylitis
             Disease Activity Index (BASDAI) ≥ 4 and Patient's Assessment of Total Back Pain score
             ≥ 4 based on a Numeric Rating Scale (NRS) at both the screening and baseline visits

          -  Participants with evidence of active inflammation in the sacroiliac (SI) joints or
             spine on MRI, or elevated high sensitivity C-reactive protein (hs-CRP) at screening

          -  Negative tuberculosis (TB) screening assessment

          -  Ability to administer subcutaneous injections or have a qualified person available to
             administer injections

          -  If female, either not of childbearing potential, defined as postmenopausal for at
             least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy
             and/or hysterectomy) or of childbearing potential and practicing an approved method of
             birth control throughout the study and for 150 days after last dose of study drug.

          -  Participant judged to be in good health as determined by the Principal Investigator
             based upon the results of medical history, laboratory profile, physical examination,
             chest X-ray, and a 12-lead electrocardiogram performed at screening

        Exclusion Criteria:

          -  Prior anti-Tumor Necrosis Factor (TNF) therapy; biologic therapy with a potential
             therapeutic impact on SpA or treated with an investigational drug of chemical or
             biologic nature within 30 days or 5 half-lives prior to the baseline visit.

          -  Fulfillment of the radiologic criterion of the modified New York criteria for
             Ankylosing Spondylitis at or prior to the screening visit

          -  Recent infection requiring treatment with intravenous (IV) anti-infectives within 30
             days prior to the baseline visit or oral anti-infectives within 14 days prior to the
             baseline visit

          -  Significant medical events or conditions that may put participants at risk for
             participation

          -  Female participants who are pregnant or breast-feeding or considering becoming
             pregnant during the study

          -  Known hypersensitivity to adalimumab or its excipients as stated in the label