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

Sponsor
Johnson & Johnson Private Limited
Study ID
NCT03733925
Phase
PHASE4
Status
Completed

Conditions

  • Arthritis, Psoriatic
  • Spondylitis, Ankylosing

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    Participants will receive golimumab 50 mg SC injections at Week 0 and q4w thereafter through Week 24.

Study Details

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.

Key Dates

Start date
Jan 7, 2019
Status verified
Jan 2025
Primary completion
Nov 15, 2021
Completion
Nov 15, 2021

Study Design

Enrollment
100 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Golimumab
    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.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 32 ]

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