drugset / Trial / NCT00111436
Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Phase 3
Completed
912 enrolled
Amgen
Immunex Corporation · collabWyeth is now a wholly owned subsidiary of Pfizer · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2003-04
- Primary completion
- 2005-07
- Completion
- 2005-07
Publications
- Results Elewski 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.
- Results Leonardi 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |