Clinical trial NCT03733925: A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
Official title: A Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of Golimumab (a Fully Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously) in the Treatment of Indian Patients With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondylitis, Ankylosing
Arthritis, Psoriatic
Lead sponsor: Johnson & Johnson Private Limited
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 32
measure: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
timeFrame: Up to Week 32
Secondary outcomes:
measure: Percentage of Ankylosing Spondylitis (AS) Participants With at Least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14
timeFrame: Week 14
measure: Percentage of Psoriatic Arthritis (PsA) Participants Meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14
timeFrame: Week 14
measure: Percentage of AS Participants With ASAS20 Criteria at Week 24
timeFrame: Week 24
measure: Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Bangalore
country: India
facility: ChanRe Rheumatology And Immunology Center And Research
city: Bhubaneswar
country: India
facility: Apollo Hospitals
city: Chennai
country: India
facility: Chennai Meenakshi Multispeciality Hospital
city: Hyderabad
country: India
facility: Nizams Institute of Medical Sciences NIMS
city: Kolkata
country: India
facility: Apollo Multispeciality Hospital Ltd
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: New Delhi
country: India
facility: Indraprastha Apollo Hospital
city: Pune
country: India
facility: Sancheti Institute for Orthopedics & Rehabilitation
Study officials:
affiliation: Johnson & Johnson Private Limited
name: Johnson & Johnson Private Limited Clinical Trial
role: STUDY_DIRECTOR
References: