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.
- Conditions
- Health Condition 1: M45- Ankylosing spondylitisHealth Condition 2: L405- Arthropathic psoriasis
- Registration Number
- CTRI/2018/12/016706
- Lead Sponsor
- Johnson and Johnson Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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 more than or equal to 4) to current or past therapies (including biologics na�¯ve 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 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) <br/ ><br>Timepoint: up to week 24 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Percentage of Ankylosing Spondylitis (AS) Participants with at least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) CriteriaTimepoint: Week 14;Percentage of AS Participants with ASAS20 CriteriaTimepoint: Week 24 <br/ ><br>;Percentage of PsA Participants Meeting the ACR20 Criteria <br/ ><br>Timepoint: Week 24;Percentage of Psoriatic Arthritis (PsA) Participants meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) <br/ ><br>Timepoint: Week 14