Clinical trial · Interventional
Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis
A Randomized, Blinded Assessor Study to Evaluate the Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent Versus Etanercept 50 mg Twice Weekly in Subjects With Moderate to Severe Plaque Psoriasis
NCT01313221CI-TRIAL-00026475REFINEcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| etanercept | Biological | — | UNRESOLVED |
| Topical agents | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Etanercept 50 mg BIW
- description
- Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept twice weekly for 12 weeks.
- interventionNames
- Biological: etanercept
- type
- EXPERIMENTAL
- label
- Etanercept 50 mg QW + Topical
- description
- Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents.
- interventionNames
- Biological: etanercept
- Drug: Topical agents
Primary outcomes (1)
- measure
- Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator). * Has a body surface area (BSA) involvement ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline. * Is a candidate for systemic therapy or phototherapy in the opinion of the investigator. * Other inclusion criteria may apply. Exclusion Criteria: * Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit. * Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept on psoriasis. * Diagnosed with medication-induced or medication-exacerbated psoriasis. * Significant concurrent medical conditions. * Has any active localized infection; requiring local intervention or chronic or localized infections. * Other exclusion criteria may apply.
References
Publications (3)
- BACKGROUNDPapp 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. PMID 25611084
- BACKGROUNDPapp 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. PMID 24980988
- BACKGROUNDGooderham 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. PMID 26330052