Phase 4
Completed N=100
A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
Spondylitis, Ankylosing · Arthritis, Psoriatic
Source: ClinicalTrials.gov NCT03733925 ↗
Enrolled (actual)
100
Serious AEs
4.0%
Results posted
Jan 2023
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 10; 18 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
10; 18 | — |
| PRIMARY Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) |
2; 2 | — |
| SECONDARY Percentage of Ankylosing Spondylitis (AS) Participants With at Least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14 |
74.5 | — |
| SECONDARY Percentage of Psoriatic Arthritis (PsA) Participants Meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14 |
84.6 | — |
| SECONDARY Percentage of AS Participants With ASAS20 Criteria at Week 24 |
66.0 | — |
| SECONDARY Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24 |
93.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT03733925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.