N/A
N=1,291
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists
Arthritis, Psoriatic · Psoriasis · Skin Diseases, Papulosquamous
Bottom Line
View on ClinicalTrials.gov: NCT00293722 ↗Enrolled (actual)
1,291
Serious AEs
6.0%
Results posted
Feb 2014
Primary outcome: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 38.1; 6.0 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Etanercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
38.1; 6.0 | — |
| SECONDARY Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 |
9.7; -6.6 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 |
4.8; -2.2 | — |
| SECONDARY Change From Baseline in Ritchie Index at Week 52 |
9.9; -4.1 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 |
60.8; -39.8 | — |
| SECONDARY Number of Participants With Nail Involvement |
597; 456; 259 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) at Week 52 |
1.8; -1.0 | — |
| SECONDARY Change From Baseline in Patient Assessment of Itching at Week 52 |
36.8; -22.7 | — |
| SECONDARY Change From Baseline in Patient Assessment of Pain at Week 52 |
65.7; -37.9 | — |
| SECONDARY Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 |
30.7; 41.4; 11.4; 7.7 | — |
Summary
The purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with PsA treated by rheumatologists.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of psoriatic arthritis
Exclusion Criteria
- Sepsis or risk for sepsis,
- Acute infection,
- Hypersensitivity against Etanercept
Data sourced from ClinicalTrials.gov (NCT00293722). 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.