N/A
Completed N=303
Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis
Arthritis, Psoriatic
Source: ClinicalTrials.gov NCT00938015 ↗
Enrolled (actual)
303
Serious AEs
21.6%
Results posted
May 2013
Primary outcomePrimary: Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1 — 7.97 Percentage of participants
Summary
The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1 |
7.97 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2 |
7.91 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3 |
4.85 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4 |
4.55 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5 |
3.37 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6 |
2.52 | — |
| SECONDARY Percentage of Participants With at Least 1 Adverse Event (AE) Per Year |
44.19; 37.77; 33.92; 34.85; 31.46; 21.38 | — |
| SECONDARY Incidence of Adverse Events and Serious Adverse Events Per Participant-Year |
145.68; 138.51; 134.23; 125.73; 117.93; 118.49 | — |
| SECONDARY Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment |
51.49 | — |
| SECONDARY Number of Joints With Active Arthritis |
11.81; 2.10; 1.80; 1.34; 1.13; 0.83 | — |
| SECONDARY Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation |
7.35; 3.33; 3.16; 3.29; 3.00; 2.23 | — |
| SECONDARY Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation |
6.51; 2.44; 2.35; 2.50; 2.22; 1.77 | — |
| SECONDARY Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA) |
26.99; 9.72; 8.87; 8.09; 7.75; 7.16 | — |
Eligibility Criteria
Inclusion Criteria
- Active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type
- At least 18 years old
- Have fulfilled reimbursement criteria for Enbrel in psoriatic arthritis of poly-articular type or oligo-articular type
- Physician decides to prescribe Enbrel or patient is already on Enbrel
- Give written informed consent at time of inclusion to study
Exclusion Criteria
NA
Data sourced from ClinicalTrials.gov (NCT00938015). 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.