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Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: etanercept (Biological); Topical agents (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24

Secondary outcome:

Percent Change in PASI From Week 12 to Weeks 16 and 20

Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24

Percentage of Participants With a PASI 50 Response

Percentage of Participants With a PASI 75 Response

Percentage of Participants With a PASI 90 Response

Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)

Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24

Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24

Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score

Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score

Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24

Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24

Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider

Health Resource Utilization: Number of Participants With Home Healthcare Visits

Health Resource Utilization: Number of Participants Requiring Paid Help With Chores

Health Resource Utilization: Number of Participants Who Needed Friend or Family Care

Health Resource Utilization: Out of Pocket Expenses

Health Resource Utilization: Employment Status

Health Resource Utilization: Productivity While Working

Health Resource Utilization: Number of Participants With Missed Hours From Work

Health Resource Utilization: Ability to Perform Daily Activities

Number of Participants With Adverse Events

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Research Site, Quebec G1J 1X7, Canada

Research Site, Quebec G1V 4X7, Canada

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, 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, Sudbury, Ontario P3C 1X8, 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, Saint-Hyacinthe, Quebec J2S 6L6, Canada

Additional Information

AmgenTrials clinical trials website

Related publications:

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):361-6. doi: 10.1111/jdv.12555. Epub 2014 Jul 1.

Starting date: April 2011
Last updated: January 27, 2015

Page last updated: August 23, 2015

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