Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis
NCT ID: NCT01313221
Last Updated: 2017-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
310 participants
INTERVENTIONAL
2011-04-30
2013-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Etanercept 50 mg BIW
Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept twice weekly for 12 weeks.
etanercept
Administered by subcutaneous injection
Etanercept 50 mg QW + Topical
Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents.
etanercept
Administered by subcutaneous injection
Topical agents
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%
Interventions
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etanercept
Administered by subcutaneous injection
Topical agents
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%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Calgary, Alberta, Canada
Research Site
Surrey, British Columbia, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Moncton, New Brunswick, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Courtice, Ontario, Canada
Research Site
Greater Sudbury, Ontario, Canada
Research Site
Markham, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
North Bay, Ontario, Canada
Research Site
Peterborough, Ontario, Canada
Research Site
Richmond Hill, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Waterloo, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saint-Hyacinthe, Quebec, Canada
Countries
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References
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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.
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.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20090647
Identifier Type: -
Identifier Source: org_study_id
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