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Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept (ReSPONSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00992394
First received: October 8, 2009
Last updated: May 14, 2013
Last verified: May 2013

October 8, 2009
May 14, 2013
January 2010
April 2013   (final data collection date for primary outcome measure)
The primary efficacy endpoint is the average 52-week Physician Global Assessment (PGA) measured as the time normalized area under curve. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00992394 on ClinicalTrials.gov Archive Site
  • Time-normalized area under the Dermatology Life Quality Index (DLQI) versus time curve. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction with Psoriasis treatment at baseline, before retreatment with etanercept 50 mg weekly, and at the end of retreatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mean Physician Global Assessment (PGA) at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Time-normalized area under the Dermatology Life Quality Index (DLQI) versus time curve. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept
Randomized Open-label Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept Treatment

This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment.

The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriasis
  • Drug: etanercept
    etanercept 50 mg once weekly as requested.
  • Drug: etanercept
    etanercept 25 mg or 50 mg as requested.
  • Arm 1
    Subjects randomized to arm 1 stop their etanercept treatment on entry into the study and may be retreated by etanercept 50 mg once weekly after medical review and agreement between the subject and the investigator
    Intervention: Drug: etanercept
  • Arm 2
    Subjects randomized to arm 2 in which subjects continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the subject and the investigator
    Intervention: Drug: etanercept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eighteen (18) years of age or older at the time of consent.
  • Previously treated with etanercept for chronic plaque psoriasis for at least 12 weeks prior to the screening visit and received a total weekly dose of 50 mg per week for at least the 6 weeks preceding the day of the screening visit
  • Having shown clinical response with a PGA inferior or equal to 1 at the screening visit.
  • PGA inferior or equal to 1 at the baseline visit.

Exclusion Criteria:

  • Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  • Evidence of active or previously known medical history of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis).
  • Any biologics other than etanercept within the 20 weeks prior to the screening visit.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Greece,   Hungary,   Italy,   Spain,   Turkey,   United Arab Emirates,   United Kingdom
 
NCT00992394
0881X1-4535, B1801021
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP