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

NCT00992394 | Completed Phase 4 Results

• 3 other identifiers: 0881X1-4535B18010212008-004439-39
• Study Type: interventional
• Target: 174
• Locations: 9 countries
• Sites: 46

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.

Conditions

Psoriasis

Keywords

Plaque psoriasis - etanercept - response maintenance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52

  Week 52

• Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment

  Baseline to Week 52

• Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment

  Baseline to Week 52

• Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment

  Baseline to Week 52

• Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment

  Baseline to Week 52

Study Arms (2)

Arm 1

OTHER

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

Arm 2

OTHER

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

Interventions

etanercept DRUG

etanercept 50 mg once weekly as requested.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (46)

Centre Hopitalier St Jacques (Place St Jacques)

Besançon, 25030, France

Location

CHU Dupuytren

Limoges, 87042, France

Location

Service de Chirurgie Infantile

Lyon, 69437, France

Location

C.H.U Nantes

Nantes, 44093, France

Location

CHU de l Archet

Nice, 06202, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

C.H.U de Reims

Reims, 51100, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

Klinik fuer Dermatologie, Allergologie und Venerologie

Berlin, 10117, Germany

Location

St. Josef-Klinikum

Bochum, 44791, Germany

Location

Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

Erlangen, 91054, Germany

Location

J. W. Goethe Universitaet Frankfurt, Zentrum fuer Dermatologie und Venerologie

Frankfurt am Main, 60590, Germany

Location

Klinikum der Albert-Ludwigs-Universitaet

Freiburg im Breisgau, 79104, Germany

Location

Universitätsklinikum-Eppendorf Martinistr. 20, Hamburg 20158

Hamburg, 20246, Germany

Location

Dermatologische Gemeinschaftspraxis Rosenbach

Osnabrück, 49078, Germany

Location

"Andreas Sygros" Hospital

Athens, 16121, Greece

Location

Papageorgiou General Peripheral Hospital of Thessaloniki

Thessaloniki, 56429, Greece

Location

Semmelweis Egyetem, Bor-, Nemikortani es Boronkologiai Klinika

Budapest, 1085, Hungary

Location

Debreceni Egyetem Orvos-és Egészségtudományi Centrum

Debrecen, 4012, Hungary

Location

Miskolci Egeszsegugyi Kozpont

Miskolc, 3529, Hungary

Location

SZTE, Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika

Szeged, 6720, Hungary

Location

Clinica Dermatologica - Universita' di Catania

Catania, 95123, Italy

Location

Centro di Ricerca Clinica Fondazione Universita' degli Studi Gabriele D'Annunzio

Chieti, 66013, Italy

Location

U.O. Dermatologia

Parma, 43100, Italy

Location

Hospital General Universitario Alicante C/ Maestro Alonso, 1

Alicante, Alicante, 3010, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Fundacion Hospital Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Virgen de la VICTORIA

Málaga, Malaga, 29010, Spain

Location

Istanbul Universitesi

Istanbul, Capa, 34390, Turkey (Türkiye)

Location

Gulhane Askeri Tip Akademisi Tip Fakultesi

Ankara, Etlik, 06010, Turkey (Türkiye)

Location

Gulhane Askeri Tip Fakultesi

Ankara, Etlik, 06018, Turkey (Türkiye)

Location

Gulhane Military Medical Academy, Faculty of Medicine

Ankara, Etlik, 06018, Turkey (Türkiye)

Location

Bezm-i Alem Vakif Universitesi Tip Fakultesi Hastanesi

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Uludag Universitesi

Bursa, Gorukle, 16059, Turkey (Türkiye)

Location

T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali

Pendik, Istanbul, 34890, Turkey (Türkiye)

Location

Gazi Universitesi

Ankara, Sihhiye, 06100, Turkey (Türkiye)

Location

Hacettepe Universitesi

Ankara, Sihhiye, 06100, Turkey (Türkiye)

Location

Hacettepe Universitesi

Ankara, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Dermatoloji Anabilim Dali

Bornova / Izmir, 35100, Turkey (Türkiye)

Location

Sheikh Khalifa Medical City

Abu Dhabi, UAE, 51900, United Arab Emirates

Location

Harrogate District Hospital

Harrogate, Harrogate, HG2 7SX, United Kingdom

Location

Whipps Cross Hospital

London, E11 1NR, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Limitations and Caveats

Enrollment in this study was slower than expected. Thus, recruitment was terminated early and only 58 percent of planned participants were randomized. As a result, no hypothesis testing was conducted and only descriptive statistics are reported.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: January 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 8, 2016
• Results First Posted: January 8, 2016

Record last verified: 2015-12

Locations

IT (3); GB (2); ES (6); FR (10); DE (7); GR (2); TU (11); AE (1); HU (4)