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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: etanercept (Drug); etanercept (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: Randomized Open-label Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept Treatment

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

Primary outcome: The primary efficacy endpoint is the average 52-week Physician Global Assessment (PGA) measured as the time normalized area under curve.

Secondary outcome:

Time-normalized area under the Dermatology Life Quality Index (DLQI) versus time curve.

Patient satisfaction with Psoriasis treatment at baseline, before retreatment with etanercept 50 mg weekly, and at the end of retreatment

Mean Physician Global Assessment (PGA) at week 52

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Besancon 25030, France

Pfizer Investigational Site, Limoges 87042, France

Pfizer Investigational Site, Lyon Cedex 03 69437, France

Pfizer Investigational Site, Nantes Cedex 01 44093, France

Pfizer Investigational Site, Nice Cedex 03 06202, France

Pfizer Investigational Site, Paris 75010, France

Pfizer Investigational Site, Pierre Benite 69495, France

Pfizer Investigational Site, Poitiers 86000, France

Pfizer Investigational Site, Reims 51100, France

Pfizer Investigational Site, Toulouse Cedex 31059, France

Pfizer Investigational Site, Berlin 10117, Germany

Pfizer Investigational Site, Bochum 44791, Germany

Pfizer Investigational Site, Erlangen 91054, Germany

Pfizer Investigational Site, Frankfurt am Main 60590, Germany

Pfizer Investigational Site, Freiburg 79104, Germany

Pfizer Investigational Site, Hamburg 20246, Germany

Pfizer Investigational Site, Osnabrueck 49078, Germany

Pfizer Investigational Site, Athens 16121, Greece

Pfizer Investigational Site, Thessaloniki 56429, Greece

Pfizer Investigational Site, Budapest 1085, Hungary

Pfizer Investigational Site, Debrecen 4012, Hungary

Pfizer Investigational Site, Miskolc 3529, Hungary

Pfizer Investigational Site, Szeged 6720, Hungary

Pfizer Investigational Site, Catania 95123, Italy

Pfizer Investigational Site, Chieti 66013, Italy

Pfizer Investigational Site, Parma 43100, Italy

Pfizer Investigational Site, Alicante 3010, Spain

Pfizer Investigational Site, Madrid 28046, Spain

Pfizer Investigational Site, Malaga 29010, Spain

Pfizer Investigational Site, Bornova / Izmir 35100, Turkey

Pfizer Investigational Site, Harrogate HG2 7SX, United Kingdom

Pfizer Investigational Site, London E11 1NR, United Kingdom

Pfizer Investigational Site, Santander, Cantabria 39008, Spain

Pfizer Investigational Site, Istanbul, Capa 34390, Turkey

Pfizer Investigational Site, Ankara, Etlik 06010, Turkey

Pfizer Investigational Site, Istanbul, Fatih 34093, Turkey

Pfizer Investigational Site, Bursa, Gorukle 16059, Turkey

Pfizer Investigational Site, Pendik, Istanbul 34890, Turkey

Pfizer Investigational Site, Alcorcon, Madrid 28922, Spain

Pfizer Investigational Site, Getafe, Madrid 28905, Spain

Pfizer Investigational Site, Ankara, Sihhiye 06100, Turkey

Pfizer Investigational Site, Abu Dhabi, UAE 51900, United Arab Emirates

Additional Information

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

Starting date: January 2010
Last updated: May 14, 2013

Page last updated: August 20, 2015

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