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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 January 2022
• Main ID: NCT03733925
• Date of registration: 05/11/2018
• Prospective Registration: Yes
• Primary sponsor: Johnson & Johnson Private Limited
• Public title: A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
• Scientific title: A Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of Golimumab (a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously) in the Treatment of Indian Patients With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
• Date of first enrolment: January 7, 2019
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03733925
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Johnson & Johnson Private Limited Clinical Trial
• Affiliation: Johnson & Johnson Private Limited

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Psoriatic

Spondylitis, Ankylosing

Intervention(s)

Drug: Golimumab

Primary Outcome(s)

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to Week 24]

Secondary Outcome(s)

Percentage of Psoriatic Arthritis (PsA) Participants meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14 [Time Frame: Week 14]

Percentage of AS Participants with ASAS20 Criteria at Week 24 [Time Frame: Week 24]

Percentage of Ankylosing Spondylitis (AS) Participants with at least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14 [Time Frame: Week 14]

Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24 [Time Frame: Week 24]

Secondary ID(s)

CNTO148SPD4001

CR108559

Source(s) of Monetary Support

Please refer to primary and secondary sponsors