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A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis

NCT03733925

CompletedPhase 4

Sponsor: Johnson & Johnson Private Limited

Conditions: Spondylitis, Ankylosing, Arthritis, Psoriatic

Interventions: Golimumab

Countries: India

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (9)
  • Bangalore, India
  • Bhubaneswar, India
  • Chennai, India
  • Hyderabad, India
  • Kolkata, India
  • New Delhi, India
  • New Delhi, India
  • New Delhi, India
  • Pune, India