Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01543204
First received: January 17, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

This study will evaluate the efficacy of etanercept in plaque psoriasis subjects who have lost a satisfactory response to adalimumab.


Condition Intervention Phase
Psoriasis
Drug: etanercept
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Efficacy of etanercept [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    To evaluate the efficacy of etanercept at week 12 as measured by static Physician Global Assessment (sPGA) in adult subjects with moderate to severe plaque psoriasis who lost a satisfactory response to adalimumab.


Secondary Outcome Measures:
  • Safety of etanercept [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    To evaluate safety of etanercept, as measured by number of subjects with Adverse Events

  • Evaluate and compare efficacy and safety in subjects with and without antibodies to adalimumab [ Time Frame: All Visits (Weeks 4, 8, 12, 16, 20 and 24) ] [ Designated as safety issue: Yes ]
    To compare and evaluate etanercept's efficacy, as assessed by sPGA, PASI and BSA and safety, as measured by number of adverse events, in subjects with and without antibodies to adalimumab

  • Effect of treatment with etanercept on patient reported outcomes [ Time Frame: 12 and 24 Weeks ] [ Designated as safety issue: No ]
    To evaulate the effect of treatment with etanercept on patient reported outcomes, as measured by Patient Satisfaction with Treatment

  • Effect of treatment with etanercept on patient reported outcomes [ Time Frame: 12 and 24 Weeks ] [ Designated as safety issue: No ]
    To evaulate the effect of treatment with etanercept on patient reported outcomes, as measured by Dermatology Life Quality index (DLQI)

  • Effect of treatment with etanercept on patient reported outcomes [ Time Frame: 12 and 24 Weeks ] [ Designated as safety issue: No ]
    To evaluate the effect of treatment with etanercept on patient reported outcomes, as measured by improvement in Work Productivity and Activity Impairment Questionnaire (WPAI);

  • Effect of treatment with etanercept on patient reported outcomes [ Time Frame: 12 and 24 Weeks ] [ Designated as safety issue: No ]
    To evaluate the effect of treatment with etanercept on patient reported outcomes, as measured by Patient assessment of itch score, of pain score and of flaking score.


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: etanercept 50 mg Drug: 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:

  • Moderate to severe plaque psoriasis
  • Loss of satisfactory response to adalimumab
  • Currently receiving or recently discontinued treatment with adalimumab

Exclusion Criteria:

  • Active skin conditions that would interfere with evaluations of the effect of investigational product on psoriasis
  • Serious medical conditions
  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: NCT01543204

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 44 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01543204     History of Changes
Other Study ID Numbers: 20101145
Study First Received: January 17, 2012
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
plaque psoriasis
etanercept
adalimumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Adalimumab
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 September 14, 2014