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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: etanercept; Drug: etanercept

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.; Drug: etanercept; etanercept 25 mg or 50 mg as requested.
Other: 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 50 mg once weekly as requested.; Drug: etanercept; etanercept 25 mg or 50 mg as requested.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52	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.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52	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).	Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
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	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).	Baseline to Week 52
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment	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).	Baseline to Week 52
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	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).	Baseline to Week 52
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	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).	Baseline to Week 52
Physician Global Assessment (PGA) of Disease Activity at Week 52	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).	Week 52

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 8, 2009
• First Submitted That Met QC Criteria: October 8, 2009
• First Posted (Estimate): October 9, 2009

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Plaque psoriasis - etanercept - response maintenance
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 0881X1-4535; B1801021 (Other Identifier: Alias Study Number); 2008-004439-39 (EudraCT Number)