A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
Condition: Spondylitis, Ankylosing; Arthritis, Psoriatic
MeSH terms: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Spondylarthropathies
Intervention: Golimumab
Intervention description: Participants will receive golimumab 50 mg SC injections at Week 0 and q4w thereafter through Week 24.
Intervention MeSH terms: Golimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety of subcutaneous (SC) golimumab in
      participants with active Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) over 24
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        For participants with Ankylosing Spondylitis (AS):

          -  Have a diagnosis of definite AS (according to the Modified New York Criteria)

          -  Either has an inadequate response (defined as Bath Ankylosing Spondylitis Disease
             Activity Index [BASDAI] greater than or equal to [>=]4) to current or past therapies
             (including biologics naïve participants). Participants who were receiving
             non-steroidal anti-inflammatory drugs (NSAIDs) or disease-modifying antirheumatic
             drugs (DMARDs) had to have received continuous therapy for 3 months at the highest
             recommended doses or had to have been unable to receive a full 3-month course of
             full-dose NSAID or DMARD therapy because of intolerance, toxicity, or
             contraindications. Maximum recommended dosages for DMARDs if used, would be:
             methotrexate 25 milligram per week (mg/week), oral corticosteroids (less than or equal
             to [<=]10 milligram per day [mg/day] of prednisone or equivalent) or sulfasalazine 3
             gram per day (g/day)

        For participants with Psoriatic Arthritis (PsA):

          -  Have PsA that was diagnosed at least 6 months prior to the first administration of
             study drug (according to the ClASsification criteria for Psoriatic ARthritis [CASPAR])

          -  Have at least 1 of the PsA subsets: Distal Interphalangeal (DIP) joint arthritis,
             polyarticular arthritis with the absence of rheumatoid nodules, arthritis mutilans,
             asymmetric peripheral arthritis, or spondylitis with peripheral arthritis

          -  Are negative for rheumatoid factors according to the reference range of the local
             laboratory conducting the test

        Exclusion Criteria:

          -  Are pregnant, nursing, or planning a pregnancy or fathering a child during the study
             or within 6 months after receiving the last administration of study drug

          -  Have a known hypersensitivity to human immunoglobulin proteins or other components of
             golimumab

          -  Have a history of latent or active granulomatous infection, including histoplasmosis,
             or coccidioidomycosis, prior to screening

          -  Have a chest radiograph within 3 months prior to the first administration of study
             drug that shows an abnormality suggestive of a malignancy or current active infection,
             including tuberculosis (TB)

          -  Have had a nontuberculous mycobacterial infection or opportunistic infection (for
             example, cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to
             screening