Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01235442
First received: October 28, 2010
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The primary hypothesis of this trial is that the addition of short courses of clobetasol propionate foam to etanercept monotherapy in subjects with moderate to severe plaque psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.


Condition Intervention Phase
Psoriasis
Drug: 1=Etanercept
Drug: 2=Clobetasol propionate foam
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 Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • PASI 75 at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.


Secondary Outcome Measures:
  • sPGA (0,1) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.

  • PASI 90 at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline.

  • Patient Satisfaction at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from "very satisfied" to "very dissatisfied."

  • Percent PASI Improvement From Baseline at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.

  • PASI 75 at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.

  • sPGA (0,1) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.


Enrollment: 592
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: etanercept and clobetasol
Etanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24)
Drug: 2=Clobetasol propionate foam
0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses
Experimental: etanercept
Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks
Drug: 1=Etanercept
50 mg SC bi-weekly for 12 weeks followed by 50 mg SC 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:

  • Subject has had stable moderate to severe plaque psoriasis for at least 6 months
  • Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline.
  • Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator

Exclusion Criteria:

  • Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
  • Subject has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept and/orclobetasol propionate foam on psoriasis.
  • Subject diagnosed with medication-induced or medication exacerbated psoriasis
  • Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection
  • Subject has a significant concurrent medical condition or laboratory abnormalities as defined in the study protocol.
  • Subject has used any of the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids.
  • Subject has used any of the following therapies within 28 days of the first dose: Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic psoriasis therapies
  • Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23 inhibitors) within 3 months of the first dose
  • Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of etanercept
  • Subject has ever used efalizumab (Raptiva®).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235442

Sponsors and Collaborators
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01235442     History of Changes
Other Study ID Numbers: 20080470
Study First Received: October 28, 2010
Results First Received: May 15, 2013
Last Updated: July 18, 2014
Health Authority: Canada: Health Canada
Canada: Institutional Review Board
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Amgen:
Psoriasis
Topical
etanercept
clobetasol propionate

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Immunoglobulin G
Clobetasol
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 29, 2014