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Study Complete
Sponsor ID
20090647

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

Sponsor ID
20090647
Clinicaltrials.gov ID
NCT01313221
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
etanercept
Type
Interventional
Masking
Single (Outcomes Assessor)
Enrollment
310
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change in Psoriasis Area and Severity Index (PASI) scores between treatment groups

Timeframe: 24 weeks

Secondary Outcome Measures

Measure the change in health resource utilization between the two treatment groups using the Economic Implications of Psoriasis patient questionnaire

Timeframe: 24 weeks

Measure the change in treatment satisfaction between the two treatment groups using the Treatment Satisfaction Questionnaire for Medications (TSQM)

Timeframe: 24 weeks

The nature, frequency, severity and relationship of treatment to all adverse events reported throughout the study will be measured.

Timeframe: 24 weeks

Measure changes in quality of life between the two treatment groups using the Dermatology Quality of Life Index

Timeframe: 24 weeks

Efficacy of the 2 treatment groups as measured by a change in PASI scores

Timeframe: 24 weeks

Efficacy of the 2 treatment groups as measured by a change in static physician’s global assessment (sPGA) of psoriasis

Timeframe: 24 weeks

Efficacy of the 2 treatment groups as measured by a change in body surface area (BSA) involvement

Timeframe: 24 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Calgary, AB, Canada, T2G 1B1
Status
Completed
Location
Research Site
Montreal, QC, Canada, H2K 4L5
Status
Completed
Location
Research Site
Moncton, NB, Canada, E1C 8X3
Status
Completed
Location
Research Site
Montreal, QC, Canada, H3Z 2S6
Status
Completed
Location
Research Site
Quebec, QC, Canada, G1J 1X7
Status
Completed
Location
Research Site
Peterborough, ON, Canada, K9J 1Z2
Status
Completed
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Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Apr 2011 - Dec 2012
    Inclusion and Exclusion 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.