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

This study is currently recruiting participants.
Verified May 2013 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01543204
First received: January 17, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  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: Allocation: Non-Randomized
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:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

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: August 2014
Estimated Primary Completion Date: August 2014 (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
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:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

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: May 6, 2013
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 May 16, 2013