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

Psoriasis Clinical Trial

— ReSPONSE  

Official title:

Randomized Open-label Study Comparing 2 Different Strategies For Management Of Subjects With Plaque Psoriasis Who Have Responded To Etanercept Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992394
• Other study ID #: 0881X1-4535
• Secondary ID: B18010212008-004
• Status: Completed
• Phase: Phase 4
• First received: October 8, 2009
• Last updated: December 4, 2015
• Start date: January 2010
• Est. completion date: April 2013

Study information

• Verified date: December 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• etanercept
etanercept 50 mg once weekly as requested.
• etanercept
etanercept 25 mg or 50 mg as requested.

Locations

Country	Name	City	State
France	Centre Hopitalier St Jacques (Place St Jacques)	Besancon
France	CHU Dupuytren	Limoges
France	Service de Chirurgie Infantile	Lyon Cedex 03
France	C.H.U Nantes	Nantes Cedex 01
France	CHU de l Archet	Nice Cedex 03
France	Hopital Saint Louis	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	CHU de Poitiers	Poitiers
France	C.H.U de Reims	Reims
France	Hôpital Purpan	Toulouse Cedex
Germany	Klinik fuer Dermatologie, Allergologie und Venerologie	Berlin
Germany	St. Josef-Klinikum	Bochum
Germany	Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum	Erlangen
Germany	J. W. Goethe Universitaet Frankfurt, Zentrum fuer Dermatologie und Venerologie	Frankfurt am Main
Germany	Klinikum der Albert-Ludwigs-Universitaet	Freiburg
Germany	Universitätsklinikum-Eppendorf Martinistr. 20, Hamburg 20158	Hamburg
Germany	Dermatologische Gemeinschaftspraxis Rosenbach	Osnabrueck
Greece	"Andreas Sygros" Hospital	Athens
Greece	Papageorgiou General Peripheral Hospital of Thessaloniki	Thessaloniki
Hungary	Semmelweis Egyetem, Bor-, Nemikortani es Boronkologiai Klinika	Budapest
Hungary	Debreceni Egyetem Orvos-és Egészségtudományi Centrum	Debrecen
Hungary	Miskolci Egeszsegugyi Kozpont	Miskolc
Hungary	SZTE, Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika	Szeged
Italy	Clinica Dermatologica - Universita' di Catania	Catania
Italy	Centro di Ricerca Clinica Fondazione Universita' degli Studi Gabriele D'Annunzio	Chieti
Italy	U.O. Dermatologia	Parma
Spain	Fundacion Hospital Alcorcon	Alcorcon	Madrid
Spain	Hospital General Universitario Alicante C/ Maestro Alonso, 1	Alicante
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Hospital La Paz	Madrid
Spain	Virgen de la VICTORIA	Malaga
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Turkey	Gazi Universitesi	Ankara	Sihhiye
Turkey	Gulhane Askeri Tip Akademisi Tip Fakultesi	Ankara	Etlik
Turkey	Gulhane Askeri Tip Fakultesi	Ankara	Etlik
Turkey	Gulhane Military Medical Academy, Faculty of Medicine	Ankara	Etlik
Turkey	Hacettepe Universitesi	Ankara	Sihhiye
Turkey	Hacettepe Universitesi	Ankara
Turkey	Ege Universitesi Tip Fakultesi Dermatoloji Anabilim Dali	Bornova / Izmir
Turkey	Uludag Universitesi	Bursa	Gorukle
Turkey	Bezm-i Alem Vakif Universitesi Tip Fakultesi Hastanesi	Istanbul	Fatih
Turkey	Istanbul Universitesi	Istanbul	Capa
Turkey	T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali	Pendik	Istanbul
United Arab Emirates	Sheikh Khalifa Medical City	Abu Dhabi	UAE
United Kingdom	Harrogate District Hospital	Harrogate
United Kingdom	Whipps Cross Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

France,  Germany,  Greece,  Hungary,  Italy,  Spain,  Turkey,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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