Phase 3
N=405
A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis
Arthritis, Psoriatic
Bottom Line
View on ClinicalTrials.gov: NCT00265096 ↗Enrolled (actual)
405
Serious AEs
21.1%
Results posted
Apr 2012
Primary outcome: Primary: American College of Rheumatology (ACR) 20 Response at Week 14 — 10; 74; 66; 140 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- golimumab (Biological); Placebo; golimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centocor, Inc.
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American College of Rheumatology (ACR) 20 Response at Week 14 |
10; 74; 66; 140 | <0.001 sig |
| PRIMARY Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24 |
0.27; -0.16; -0.02; -0.09 | 0.015 sig |
| SECONDARY Psoriasis Area and Severity Index (PASI) 75 Response at Week 14 in a Subset of Patients With ≥ 3 Percent Body Surface Area (BSA) Psoriasis Skin Involvement at Baseline |
2; 44; 63; 107 | <0.001 sig |
| SECONDARY Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24 |
0.0000; 0.2500; 0.3750; 0.2500 | <0.001 sig |
| SECONDARY Change From Baseline in the Physical Component Summary Score of the 36-item Short Form Health Survey at Week 14 |
0.63; 6.53; 7.85; 7.19 | <0.001 sig |
| SECONDARY American College of Rheumatology 20 at Week 24 |
14; 76; 89; 165 | <0.001 sig |
Summary
The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray related to joint damage, psoriasis skin lesions, physical function, and quality of life.
Eligibility Criteria
Inclusion Criteria
- Psoriatic arthritis (PsA) diagnosed > 6months prior
- Active PsA at the time of screening and at baseline visits, with >= 3 swollen joints and >= 3 tender joints
- Have at least 1 of the PsA subsets (DIP joint arthritis, polyarticular arthritis without rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis)
- Active plaque psoriasis with a lesion >= 2cm in diameter
- Active arthritis despite current disease modifying anti-rheumatic drug (DMARD) or nonsteroidal anti-inflammatory drug (NSAID) therapy
- Stable doses of methotrexate, low-dose corticosteroids, and NSAIDs are permitted.
Exclusion Criteria
- No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)
- No treatment with alefacept or efalizumab within 3 months prior to the first study drug injection
- No DMARDs other than methotrexate, or immunosuppressive drugs within 4 weeks prior to the first study drug injection.
Data sourced from ClinicalTrials.gov (NCT00265096). 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.