Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis
REFINE
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
1 other identifier
interventional
310
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2011
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 11, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
May 2, 2014
CompletedMarch 15, 2017
February 1, 2017
1.7 years
February 24, 2011
December 10, 2013
February 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value \* 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.
Week 12 and Week 24
Secondary Outcomes (22)
Percent Change in PASI From Week 12 to Weeks 16 and 20
Week 12, Week 16 and Week 20
Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24
Baseline and Weeks 12, 16, 20, and 24
Percentage of Participants With a PASI 50 Response
Baseline and Weeks 12, 16, 20 and 24
Percentage of Participants With a PASI 75 Response
Baseline and Weeks 12, 16, 20 and 24
Percentage of Participants With a PASI 90 Response
Baseline and Weeks 12, 16, 20 and 24
- +17 more secondary outcomes
Study Arms (2)
Etanercept 50 mg BIW
ACTIVE COMPARATORFollowing 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept twice weekly for 12 weeks.
Etanercept 50 mg QW + Topical
EXPERIMENTALFollowing 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents.
Interventions
Administered by subcutaneous injection
Topical agents prescribed at the discretion of the Principal Investigator and were are limited to the following: * hydrocortisone 2.5% * betamethasone valerate 0.1% * betamethasone dipropionate 0.05% * clobetasol 0.05% * calcitriol * calcipotriol plus betamethsone dipropionate 0.05%
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (24)
Research Site
Calgary, Alberta, T2G 1B1, Canada
Research Site
Surrey, British Columbia, V3R 6A7, Canada
Research Site
Vancouver, British Columbia, V5Z 4E8, Canada
Research Site
Winnipeg, Manitoba, R3C 0N2, Canada
Research Site
Moncton, New Brunswick, E1C 8X3, Canada
Research Site
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Research Site
St. John's, Newfoundland and Labrador, A1C 2H5, Canada
Research Site
Halifax, Nova Scotia, B3H 1Z4, Canada
Research Site
Courtice, Ontario, L1E 3C3, Canada
Research Site
Greater Sudbury, Ontario, P3C 1X8, Canada
Research Site
Markham, Ontario, L3P 1A8, Canada
Research Site
Mississauga, Ontario, L5H 1G9, Canada
Research Site
North Bay, Ontario, P1B 3Z7, Canada
Research Site
Peterborough, Ontario, K9J 1Z2, Canada
Research Site
Richmond Hill, Ontario, L4B 1A5, Canada
Research Site
Toronto, Ontario, M3H 5Y8, Canada
Research Site
Toronto, Ontario, M4V 1R1, Canada
Research Site
Waterloo, Ontario, N2J 1C4, Canada
Research Site
Windsor, Ontario, N8W 5L7, Canada
Research Site
Montreal, Quebec, H2K 4L5, Canada
Research Site
Montreal, Quebec, H3Z 2S6, Canada
Research Site
Québec, Quebec, G1J 1X7, Canada
Research Site
Québec, Quebec, G1V 4X7, Canada
Research Site
Saint-Hyacinthe, Quebec, J2S 6L6, Canada
Related Publications (3)
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.
PMID: 25611084BACKGROUNDPapp 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: 24980988BACKGROUNDGooderham 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: 26330052BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2011
First Posted
March 11, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2012
Study Completion
May 1, 2013
Last Updated
March 15, 2017
Results First Posted
May 2, 2014
Record last verified: 2017-02