Phase 3
N=480
A Study of Golimumab in Participants With Active Psoriatic Arthritis
Arthritis, Psoriatic
Bottom Line
View on ClinicalTrials.gov: NCT02181673 ↗Enrolled (actual)
480
Serious AEs
4.6%
Results posted
Dec 2017
Primary outcome: Primary: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14 — 21.8; 75.1 Percentage of Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Golimumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14 |
21.8; 75.1 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14 |
-0.12; -0.60 | — |
| SECONDARY Percentage of Participants Who Achieved an ACR 50 Response at Week 14 |
6.3; 43.6 | — |
| SECONDARY Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14 |
13.6; 59.2 | — |
| SECONDARY Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 |
1.95; -0.36 | — |
| SECONDARY Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline |
-0.8; -1.8 | — |
| SECONDARY Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline |
-2.8; -7.8 | — |
| SECONDARY Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14 |
2.69; 8.65 | — |
| SECONDARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24 |
6.3; 53.5 | — |
| SECONDARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14 |
2.1; 24.5 | — |
| SECONDARY Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14 |
0.97; 5.33 | — |
Summary
The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).
Eligibility Criteria
Inclusion Criteria
- Have had psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study agent
- Have a diagnosis of active PSA as defined by 5 or more swollen joints and 5 or more tender joints at Screening and at Baseline and C-reactive protein >=0.6 milligram per deciliter (mg/dL) at Screening
- Have active plaque psoriasis or a documented history of plaque psoriasis
- Have active PsA despite current or previous disease-modifying antirheumatic drugs (DMARD) and/or nonsteroidal anti-inflammatory drug (NSAID) therapy. DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID intolerance
Exclusion Criteria
- Have other inflammatory diseases that might confound the evaluations of benefit of Golimumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
- Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent
- Have used any biologic agents that are targeted for reducing tumor necrosis factors (TNF) alpha, including but not limited to Infliximab, Etanercept, Adalimumab, Golimumab, and Certolizumab Pegol
- Have ever used cytotoxic drugs, including Chlorambucil, Cyclophosphamide, Nitrogen mustard, or other Alkylating agents
Data sourced from ClinicalTrials.gov (NCT02181673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.