Clinical trial NCT01313221: Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: plaque psoriasis
moderate
severe
etanercept
Enbrel
topical
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The recommended starting dose of etanercept for adult plaque psoriasis patients is a 50 mg dose given twice a week (BIW) for 3 months followed by a reduction to a maintenance dose of 50 mg once weekly (QW). While most patients with moderate to severe plaque psoriasis are managed satisfactorily on etanercept monotherapy, a proportion may require a modified or alternative treatment regimen (eg, to handle flares or loss of effect) at some point during their chronic management. Despite the clinical need, no published data from randomized controlled studies are currently available that demonstrate efficacy and safety of combined etanercept-based regimens in patients with plaque psoriasis.

The addition of an as-needed topical medication to the step-down dose of etanercept 50 mg once weekly administered after the initial 12 week period of 50 mg twice weekly may be a potential option for patients who may require adjunctive therapy. This study aimed to provide data on this treatment option by estimating the difference in mean percent change in Psoriasis Area and Severity Index (PASI) scores between step-down etanercept 50 mg once weekly supplemented with as-needed topical medication and continuous treatment with etanercept 50 mg twice weekly.

Eligible patients will be enrolled in the study and will receive etanercept 50 mg twice weekly for 12 weeks. After 12 weeks of etanercept treatment, participants will be randomized in a 1:1 ratio to 1 of 2 treatment groups.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24
timeFrame: Week 12 and Week 24
Secondary outcomes:
measure: Percent Change in PASI From Week 12 to Weeks 16 and 20
timeFrame: Week 12, Week 16 and Week 20
measure: Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24
timeFrame: Baseline and Weeks 12, 16, 20, and 24
measure: Percentage of Participants With a PASI 50 Response
timeFrame: Baseline and Weeks 12, 16, 20 and 24
measure: Percentage of Participants With a PASI 75 Response
timeFrame: Baseline and Weeks 12, 16, 20 and 24
measure: Percentage of Participants With a PASI 90 Response
timeFrame: Baseline and Weeks 12, 16, 20 and 24
measure: Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)
timeFrame: Weeks 12, 16, 20, and 24
measure: Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24
timeFrame: Weeks 12, 16, 20, and 24
measure: Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24
timeFrame: Baseline and Weeks 12, 16, 20, and 24
measure: Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score
timeFrame: Week 12 and Week 24
measure: Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score
timeFrame: Baseline and Week 12 and Week 24
measure: Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24
timeFrame: Week 12 and Week 24
measure: Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24
timeFrame: Baseline and Weeks 12 and 24
measure: Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider
timeFrame: Baseline and 24 weeks
measure: Health Resource Utilization: Number of Participants With Home Healthcare Visits
timeFrame: Baseline and 24 weeks
measure: Health Resource Utilization: Number of Participants Requiring Paid Help With Chores
timeFrame: Baseline and 24 weeks
measure: Health Resource Utilization: Number of Participants Who Needed Friend or Family Care
timeFrame: Baseline and 24 weeks
measure: Health Resource Utilization: Out of Pocket Expenses
timeFrame: Baseline and 24 weeks
measure: Health Resource Utilization: Employment Status
timeFrame: Baseline and 24 weeks
measure: Health Resource Utilization: Productivity While Working
timeFrame: Baseline and 24 weeks
measure: Health Resource Utilization: Number of Participants With Missed Hours From Work
timeFrame: Baseline and 24 weeks
measure: Health Resource Utilization: Ability to Perform Daily Activities
timeFrame: Baseline and 24 weeks
measure: Number of Participants With Adverse Events
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Moncton
country: Canada
facility: Research Site
state: New Brunswick
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Courtice
country: Canada
facility: Research Site
state: Ontario
city: Markham
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: North Bay
country: Canada
facility: Research Site
state: Ontario
city: Peterborough
country: Canada
facility: Research Site
state: Ontario
city: Richmond Hill
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Saint-Hyacinthe
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Quebec
country: Canada
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.