A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of A… (NCT03733925) | Clinical Trial Compass
CompletedPhase 4
A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
India100 participantsStarted 2019-01-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 acc…
What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to Week 32
2
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)