Health Condition 1: M45- Ankylosing spondylitis Health Condition 2: L405- Arthropathic psoriasis
Conditions
Interventions
Intervention1: Golimumab: Participants will receive golimumab 50mg SC injections at Week 0 and every 4 weeks thereafter through Week 24.
Control Intervention1: NA: NA
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion 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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Timepoint: up to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;Percentage of PsA Participants Meeting the ACR20 Criteria Timepoint: Week 24;Percentage of Psoriatic Arthritis (PsA) Participants meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) Timepoint: Week 14 | — |
Countries
India
Contacts
Public ContactPrashant Desai
Johnson & Johnson Private Limited
Outcome results
None listed