N/A
N=149
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists
Arthritis, Psoriatic · Psoriasis · Skin Diseases, Papulosquamous
Bottom Line
View on ClinicalTrials.gov: NCT00293709 ↗Enrolled (actual)
149
Serious AEs
1.3%
Results posted
Feb 2014
Primary outcome: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 24.2; 1.3 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) |
24.2; 1.3 | — |
| SECONDARY Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 |
24.5; -17.8 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52 |
15.1; -11.8 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 |
5.1; -2.2 | — |
| SECONDARY Change From Baseline in Ritchie Index at Week 52 |
15.8; -3.6 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 |
60.4; -35.8 | — |
| SECONDARY Number of Participants With Nail Involvement |
103; 81; 50 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) at Week 52 |
1.6; -0.6 | — |
| SECONDARY Change From Baseline in Patient Assessment of Itching at Week 52 |
44.0; -26.1 | — |
| SECONDARY Change From Baseline in Patient Assessment of Pain at Week 52 |
60.0; -37.5 | — |
| SECONDARY Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 |
33.5; 40.5; 11.7; 9.4 | — |
Summary
The purpose of this study is to evaluate the safety profile and the effectiveness of etanercept under usual care settings in patients with PsA treated by dermatologists.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of Psoriatic Arthritis
Exclusion Criteria
- Sepsis or risk for sepsis,
- Acute infection,
- Hypersensitive against Etanercept
Data sourced from ClinicalTrials.gov (NCT00293709). 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.