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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: December 4, 2015
Last verified: December 2015
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: etanercept
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Open-label Study Comparing 2 Different Strategies For Management Of Subjects With Plaque Psoriasis Who Have Responded To Etanercept Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks*7days + 1.


Secondary Outcome Measures:
  • Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).

  • Physician Global Assessment (PGA) of Disease Activity at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).


Enrollment: 174
Study Start Date: January 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: etanercept
etanercept 50 mg once weekly as requested.
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
Drug: etanercept
etanercept 25 mg or 50 mg as requested.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00992394

  Hide Study Locations
Locations
France
Centre Hopitalier St Jacques (Place St Jacques)
Besancon, France, 25030
CHU Dupuytren
Limoges, France, 87042
Service de Chirurgie Infantile
Lyon Cedex 03, France, 69437
C.H.U Nantes
Nantes Cedex 01, France, 44093
CHU de l Archet
Nice Cedex 03, France, 06202
Hopital Saint Louis
Paris, France, 75010
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
CHU de Poitiers
Poitiers, France, 86000
C.H.U de Reims
Reims, France, 51100
Hôpital Purpan
Toulouse Cedex, France, 31059
Germany
Klinik fuer Dermatologie, Allergologie und Venerologie
Berlin, Germany, 10117
St. Josef-Klinikum
Bochum, Germany, 44791
Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
Erlangen, Germany, 91054
J. W. Goethe Universitaet Frankfurt, Zentrum fuer Dermatologie und Venerologie
Frankfurt am Main, Germany, 60590
Klinikum der Albert-Ludwigs-Universitaet
Freiburg, Germany, 79104
Universitätsklinikum-Eppendorf Martinistr. 20, Hamburg 20158
Hamburg, Germany, 20246
Dermatologische Gemeinschaftspraxis Rosenbach
Osnabrueck, Germany, 49078
Greece
"Andreas Sygros" Hospital
Athens, Greece, 16121
Papageorgiou General Peripheral Hospital of Thessaloniki
Thessaloniki, Greece, 56429
Hungary
Semmelweis Egyetem, Bor-, Nemikortani es Boronkologiai Klinika
Budapest, Hungary, 1085
Debreceni Egyetem Orvos-és Egészségtudományi Centrum
Debrecen, Hungary, 4012
Miskolci Egeszsegugyi Kozpont
Miskolc, Hungary, 3529
SZTE, Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika
Szeged, Hungary, 6720
Italy
Clinica Dermatologica - Universita' di Catania
Catania, Italy, 95123
Centro di Ricerca Clinica Fondazione Universita' degli Studi Gabriele D'Annunzio
Chieti, Italy, 66013
U.O. Dermatologia
Parma, Italy, 43100
Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Fundacion Hospital Alcorcon
Alcorcon, Madrid, Spain, 28922
Hospital Universitario de Getafe
Getafe, Madrid, Spain, 28905
Hospital General Universitario Alicante C/ Maestro Alonso, 1
Alicante, Spain, 3010
Hospital La Paz
Madrid, Spain, 28046
Virgen de la VICTORIA
Malaga, Spain, 29010
Turkey
Istanbul Universitesi
Istanbul, Capa, Turkey, 34390
Gulhane Askeri Tip Akademisi Tip Fakultesi
Ankara, Etlik, Turkey, 06010
Gulhane Askeri Tip Fakultesi
Ankara, Etlik, Turkey, 06018
Gulhane Military Medical Academy, Faculty of Medicine
Ankara, Etlik, Turkey, 06018
Bezm-i Alem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, Fatih, Turkey, 34093
Uludag Universitesi
Bursa, Gorukle, Turkey, 16059
T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali
Pendik, Istanbul, Turkey, 34890
Gazi Universitesi
Ankara, Sihhiye, Turkey, 06100
Hacettepe Universitesi
Ankara, Sihhiye, Turkey, 06100
Hacettepe Universitesi
Ankara, Turkey
Ege Universitesi Tip Fakultesi Dermatoloji Anabilim Dali
Bornova / Izmir, Turkey, 35100
United Arab Emirates
Sheikh Khalifa Medical City
Abu Dhabi, UAE, United Arab Emirates, 51900
United Kingdom
Harrogate District Hospital
Harrogate, United Kingdom, HG2 7SX
Whipps Cross Hospital
London, United Kingdom, E11 1NR
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00992394     History of Changes
Other Study ID Numbers: 0881X1-4535  B1801021  2008-004439-39 
Study First Received: October 8, 2009
Results First Received: April 3, 2014
Last Updated: December 4, 2015
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
Plaque psoriasis - etanercept - response maintenance

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on December 09, 2016