drugset / Trial / NCT01313221
Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis
RandomizedParallel-groupSingle-blindTreatment
Summary
To estimate the difference in effectiveness between treatment with etanercept 50 mg twice weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN) topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.
Timeline
- Start
- 2011-04
- Primary completion
- 2012-12
- Completion
- 2013-05
Publications
- Background Papp KA, Barber K, Bissonnette R, Bourcier M, Lynde CW, Poulin Y, Shelton J, Garces K, Toole J, Poulin-Costello M. Improvements in patient-reported outcomes in patients with psoriasis receiving etanercept plus topical therapies: results from REFINE. J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1555-61. doi: 10.1111/jdv.12934. Epub 2015 Jan 21.
- Background Papp KA, Barber K, Bissonnette R, Bourcier M, Lynde CW, Poulin Y, Shelton J, Toole J, Vieira A, Poulin-Costello M. A Randomized, blinded assessor study to Evaluate the efFIcacy and safety of etanercept 50 mg once weekly plus as Needed topical agent vs. Etanercept 50 mg twice weekly in patients with moderate to severe plaque psoriasis (REFINE). J Eur Acad Dermatol Venereol. 2015 Feb;29(2):361-366. doi: 10.1111/jdv.12555. Epub 2014 Jul 1.
- Background Gooderham MJ, Poulin-Costello M, Shelton J, Bayan N, Papp KA. Predictors of Topical Use in Psoriasis Patients in the REFINE Study. J Cutan Med Surg. 2016 Mar-Apr;20(2):106-12. doi: 10.1177/1203475415604322. Epub 2015 Sep 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcipotriol | Small molecule | — | Topical |
| Subject | Calcitriol | Small molecule | — | Topical |
| Subject | Clobetasol | Small molecule | 0.05 % | Topical |
| Subject | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Subject | Hydrocortisone | Other / unclassified | 2.5 % | Topical |
| Subject | betamethasone dipropionate | Small molecule | 0.05 % | Topical |
| Subject | betamethasone valerate | Small molecule | 0.1 % | Topical |