REFINE: Canada Only - Etanercept Derm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01313221
First received: February 24, 2011
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

This is a phase 3b, multicentre, randomized, open-label study wherein eligible subjects will be enrolled in the study and will receive etanercept 50 mg twice weekly for 12 weeks. After 12 weeks of etanercept treatment, subjects will be randomized in a 1:1 ratio to 1 of 2 treatment groups.


Condition Intervention Phase
Psoriasis
Biological: etanercept
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Change in Psoriasis Area and Severity Index (PASI) scores between treatment groups [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure the change in health resource utilization between the two treatment groups using the Economic Implications of Psoriasis patient questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Measure the change in treatment satisfaction between the two treatment groups using the Treatment Satisfaction Questionnaire for Medications (TSQM) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • The nature, frequency, severity and relationship of treatment to all adverse events reported throughout the study will be measured. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Measure changes in quality of life between the two treatment groups using the Dermatology Quality of Life Index [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Efficacy of the 2 treatment groups as measured by a change in PASI scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Efficacy of the 2 treatment groups as measured by a change in static physician's global assessment (sPGA) of psoriasis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Efficacy of the 2 treatment groups as measured by a change in body surface area (BSA) involvement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: April 2011
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Etancercpet 50 mg Twice Weekly
Following 12 weeks of etanercept 50 mg twice weekly, subjects are randomized to 50 mg twice weekly for 12 weeks.
Biological: etanercept
50 mg, SC (subcutaneously), twice weekly for 12 weeks
Active Comparator: Etanercept 50 mg Once Weekly
Following 12 weeks of etanercept 50 mg twice weekly, subjects are randomized to 50 mg once weekly plus as needed topical agents
Biological: etanercept
50 mg, SC (subcutaneously), twice weekly for 12 weeks
Biological: etanercept
50 mg, SC (subcutaneously), once weekly for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 BSA involvement ≥ 10% and 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313221

Locations
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2G 1B1
Canada, British Columbia
Research Site
Surrey, British Columbia, Canada, V3R 6A7
Research Site
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, New Brunswick
Research Site
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Research Site
St. John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Research Site
Courtice, Ontario, Canada, L1E 3C3
Research Site
Markham, Ontario, Canada, L3P 1A8
Research Site
Mississauga, Ontario, Canada, L5H 1G9
Research Site
North Bay, Ontario, Canada, P1B 3Z7
Research Site
Peterborough, Ontario, Canada, K9J 1Z2
Research Site
Richmond Hill, Ontario, Canada, L4B 1A5
Research Site
Sudbury, Ontario, Canada, P3C 1X8
Research Site
Toronto, Ontario, Canada, M3H 5Y8
Research Site
Toronto, Ontario, Canada, M4V 1R1
Research Site
Waterloo, Ontario, Canada, N2J 1C4
Research Site
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H2K 4L5
Research Site
Montreal, Quebec, Canada, H3Z 2S6
Research Site
Saint-Hyacinthe, Quebec, Canada, J2S 6L6
Canada
Research Site
Quebec, Canada, G1J 1X7
Research Site
Quebec, Canada, G1V 4X7
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01313221     History of Changes
Other Study ID Numbers: 20090647
Study First Received: February 24, 2011
Last Updated: August 19, 2013
Health Authority: Canada: Health Canada

Keywords provided by Amgen:
plaque psoriasis
moderate
severe
etanercept
Enbrel
topical

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 21, 2014