Phase 4
Completed N=120
Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
Source: ClinicalTrials.gov NCT00581555 ↗Enrolled (actual)
120
Serious AEs
2.5%
Results posted
Apr 2012
Primary outcomePrimary: Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo) — 2.9; -1.8 scores on a scale — p=<0.001
Summary
The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo) |
2.9; -1.8 | <0.001 sig |
| SECONDARY PASI Area Under the Curve (AUC) Between Randomization and Week 24 |
20.7; 20.7; 7.0; 5.0; 6.7; 4.4 | 0.999 |
| SECONDARY Change From Randomization in PGA Score to Week 24 |
0.9; 0.2 | 0.049 sig |
| SECONDARY Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization |
63.77; 36.23 | 0.002 sig |
| SECONDARY Probability of Being Relapse Free During the 24 Weeks After Randomization |
0.93; 0.91; 0.84; 0.84; 0.44; 0.69 | 0.0003 sig |
| SECONDARY Percent (%) Change of PASI Score From Randomization to Week 24 |
121.9; -13.3 | 0.001 sig |
| SECONDARY Change From Randomization in DLQI to Week 24 |
2.0; -0.4 | 0.139 |
| SECONDARY DLQI at Each Visit From Baseline |
4.1; 4.0; 3.0; 4.0; 1.5; 1.9 | 0.956 |
| SECONDARY Percentage of Rebound Effects |
26.67; 0.00 | 0.1196 |
Eligibility Criteria
Inclusion Criteria
- Between age 18 and 70 years
- Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.
Exclusion Criteria
- Evidence of skin conditions other than psoriasis
- Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or disease-modifying antirheumatic drugs (DMARD) with 28 days of screening
- ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin
- Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
- Corticosteroid dose of prednisone >10 mg/day
- Serious infection
- Receipt of any live vaccine
- Abnormal hematology or chemistry
- Body mass index (BMI) > 38
- Pregnancy or Breastfeeding
- Significant concurrent medical conditions
Data sourced from ClinicalTrials.gov (NCT00581555). 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.