Clinical trial NCT00992394: Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept
Official title: Randomized Open-label Study Comparing 2 Different Strategies For Management Of Subjects With Plaque Psoriasis Who Have Responded To Etanercept Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Plaque psoriasis - etanercept - response maintenance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52
timeFrame: Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: 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
timeFrame: Baseline to Week 52
measure: Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment
timeFrame: Baseline to Week 52
measure: 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
timeFrame: Baseline to Week 52
measure: 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
timeFrame: Baseline to Week 52
measure: Physician Global Assessment (PGA) of Disease Activity at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hopitalier St Jacques (Place St Jacques)
city: Limoges
country: France
facility: CHU Dupuytren
city: Lyon Cedex 03
country: France
facility: Service de Chirurgie Infantile
city: Nantes Cedex 01
country: France
facility: C.H.U Nantes
city: Nice Cedex 03
country: France
facility: CHU de l Archet
city: Paris
country: France
facility: Hopital Saint Louis
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: C.H.U de Reims
city: Toulouse Cedex
country: France
facility: Hôpital Purpan
city: Berlin
country: Germany
facility: Klinik fuer Dermatologie, Allergologie und Venerologie
city: Bochum
country: Germany
facility: St. Josef-Klinikum
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
city: Frankfurt am Main
country: Germany
facility: J. W. Goethe Universitaet Frankfurt, Zentrum fuer Dermatologie und Venerologie
city: Freiburg
country: Germany
facility: Klinikum der Albert-Ludwigs-Universitaet
city: Hamburg
country: Germany
facility: Universitätsklinikum-Eppendorf Martinistr. 20, Hamburg 20158
city: Osnabrueck
country: Germany
facility: Dermatologische Gemeinschaftspraxis Rosenbach
city: Athens
country: Greece
facility: "Andreas Sygros" Hospital
city: Thessaloniki
country: Greece
facility: Papageorgiou General Peripheral Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Bor-, Nemikortani es Boronkologiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos-és Egészségtudományi Centrum
city: Miskolc
country: Hungary
facility: Miskolci Egeszsegugyi Kozpont
city: Szeged
country: Hungary
facility: SZTE, Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika
city: Catania
country: Italy
facility: Clinica Dermatologica - Universita' di Catania
city: Chieti
country: Italy
facility: Centro di Ricerca Clinica Fondazione Universita' degli Studi Gabriele D'Annunzio
city: Parma
country: Italy
facility: U.O. Dermatologia
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Alcorcon
country: Spain
facility: Fundacion Hospital Alcorcon
state: Madrid
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante C/ Maestro Alonso, 1
city: Madrid
country: Spain
facility: Hospital La Paz
city: Malaga
country: Spain
facility: Virgen de la VICTORIA
city: Istanbul
country: Turkey
facility: Istanbul Universitesi
state: Capa
city: Ankara
country: Turkey
facility: Gulhane Askeri Tip Akademisi Tip Fakultesi
state: Etlik
city: Ankara
country: Turkey
facility: Gulhane Askeri Tip Fakultesi
state: Etlik
city: Ankara
country: Turkey
facility: Gulhane Military Medical Academy, Faculty of Medicine
state: Etlik
city: Istanbul
country: Turkey
facility: Bezm-i Alem Vakif Universitesi Tip Fakultesi Hastanesi
state: Fatih
city: Bursa
country: Turkey
facility: Uludag Universitesi
state: Gorukle
city: Pendik
country: Turkey
facility: T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali
state: Istanbul
city: Ankara
country: Turkey
facility: Gazi Universitesi
state: Sihhiye
city: Ankara
country: Turkey
facility: Hacettepe Universitesi
state: Sihhiye
city: Ankara
country: Turkey
facility: Hacettepe Universitesi
city: Bornova / Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Dermatoloji Anabilim Dali
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Khalifa Medical City
state: UAE
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
city: London
country: United Kingdom
facility: Whipps Cross Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: