Phase 3
Completed N=312
A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
Arthritis, Psoriatic
Source: ClinicalTrials.gov NCT01077362 ↗
Enrolled (actual)
312
Serious AEs
3.1%
Results posted
Feb 2014
Primary outcomePrimary: Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. — 20.2; 43.7; 43.8; 43.8 Percentage of participants — p=<0.001
Summary
The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. |
20.2; 43.7; 43.8; 43.8 | <0.001 sig |
| SECONDARY Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) |
-0.03; -0.21; -0.22; -0.21 | 0.002 sig |
| SECONDARY Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 |
5.0; 51.3; 55.6; 53.4 | <0.001 sig |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24 |
6.7; 17.5; 22.9; 20.2 | 0.018 sig |
| SECONDARY Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002 |
0.97; 0.40; 0.39; 0.40 | 0.017 sig |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24 |
2.9; 6.8; 8.6; 7.7 | 0.171 |
Eligibility Criteria
Inclusion Criteria
- Have had a documented diagnosis of psoriatic arthritis (PsA) at least 6 months
- Have a diagnosis of active PsA at the time of entry into the study with at least 5 tender and 5 swollen joints at baseline
- May have previously received at least 8 weeks of etanercept, adalimumab, golimumab or certolizumab pegol or at least 14 weeks of infliximab or proven inability to tolerate anti-TNF therapy for 8-14 weeks
- If the patient is using methotrexate, they should have started treatment at a dose not to exceed 25 mg/week at least 3 months prior to the beginning of the study and should have no serious toxic side effects attributable to methotrexate
Exclusion Criteria
- Have other inflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
- Have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but not limited to ustekinumab and ABT-874
- Have used infliximab, golimumab or certolizumab pegol within 12 weeks of first study drug injection, or etanercept or adalimumab within 8 weeks of first study drug injection
- Have a medical history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening
- Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years of the beginning of the study
Data sourced from ClinicalTrials.gov (NCT01077362). 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. Informational only — not medical advice.