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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 4

Conditions: Spondylitis, Ankylosing; Arthritis, Psoriatic

Treatments: Drug: Golimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03733925

CR108559

CNTO148SPD4001 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This post-marketing study will evaluate safety and efficacy profile of golimumab (a fully human anti-Tumour Necrosis Factor alpha [TNF-alpha] monoclonal antibodies [mAb], administered subcutaneously) in a real-world in Indian participants with active spondyloarthropathy of ankylosing spondylitis (AS) or psoriatic arthritis (PsA). AS is a chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, axial skeleton, entheses, and peripheral joints. PsA is a chronic, inflammatory, usually rheumatoid factor negative arthritis that is associated with psoriasis. Golimumab binds with high affinity to human TNF-alpha and inhibits TNF-alpha bioactivity, TNF-alpha-mediated cell cytotoxicity and TNF-alpha mediated endothelial cell activation. Golimumab also induces activation of complement-mediated cell lysis and reduces the development of arthritis. Study evaluation includes efficacy (efficacy parameters for AS and PsA) and safety. Participant's safety will be monitored throughout the study. The total duration of study will be approximately 24 weeks.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Golimumab

Experimental group

Description:

Participants will receive golimumab 50 milligram (mg) subcutaneous (SC) injection at Week 0 and every 4 weeks (q4w) thereafter through Week 24. Concomitant medications may be allowed on a case by case basis as per the physician's judgement.

Treatment:

Drug: Golimumab