Clinical trial · Interventional
Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psoriasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etanercept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 50 mg
- description
- 50 mg once weekly
- interventionNames
- Drug: Etanercept
- type
- EXPERIMENTAL
- label
- 100 mg
- description
- 50 mg twice weekly
- interventionNames
- Drug: Etanercept
Primary outcomes (2)
- measure
- Subject incidence of adverse events, including infectious episodes
- timeFrame
- 72 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol) Exclusion Criteria: * Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit * Pregnant or breast-feeding females * Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
References
Publications (2)
- RESULTElewski B, Leonardi C, Gottlieb AB, Strober BE, Simiens MA, Dunn M, Jahreis A. Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis. Br J Dermatol. 2007 Jan;156(1):138-42. doi: 10.1111/j.1365-2133.2006.07585.x. PMID 17199580
- RESULTLeonardi C, Strober B, Gottlieb AB, Elewski BE, Ortonne JP, van de Kerkhof P, Chiou CF, Dunn M, Jahreis A. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. J Drugs Dermatol. 2010 Aug;9(8):928-37. PMID 20684143