Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

NCT00195507 | Completed Phase 4 Results

• 1 other identifier: 0881A6-101764
• Study Type: interventional
• Target: 720
• Locations: 19 countries
• Sites: 127

Brief Summary

This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks

  Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).

  54 weeks

Secondary Outcomes (3)

• Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline

  54 weeks

• Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"

  54 weeks

• Number of Patients With Survey Response of "Somewhat Satisfied" or Better

  54 weeks

Interventions

Etanercept DRUG

Eligibility Criteria

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

You may qualify if:

• Stable, active plaque psoriasis
• Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate

You may not qualify if:

• Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study
• Systemic psoriasis therapy within 28 days prior

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (127)

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Feldkirch, Austria

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Vienna, 1090, Austria

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Vienna, 1160, Austria

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Brussels, B-1070, Belgium

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Brussels, B-1200, Belgium

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Edegem, B-2650, Belgium

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Ghent, B-9000, Belgium

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Leuven, B-3000, Belgium

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Liège, 4000, Belgium

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Prague, 180 01, Czechia

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Aarhus C, 8000, Denmark

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Odense C, 5000, Denmark

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Roskilde, 4000, Denmark

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Kuopio, 702 11, Finland

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Lahti, 151 70, Finland

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Besançon, 25030, France

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Bordeaux, 33075, France

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Boulogne-Billancourt, 92104, France

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Brest, 29609, France

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Créteil, 94000, France

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Dijon, 21079, France

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Lille, 59037, France

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Lyon, 60002, France

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Lyon, 69437, France

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Marseille, 13915, France

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Marseille Cédex 09, 13009, France

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Montpellier Cédex 5, 34000, France

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Nancy, 54000, France

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Nantes, 44093, France

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Nice, 06200, France

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Nîmes, 30029, France

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Paris, 75018, France

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Pessac, 33600, France

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Pierre-Bénite, 69495, France

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Poitiers, 86000, France

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Reims, 51092, France

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Rouen, 76000, France

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Saint-Etienne, 42055, France

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Strasbourg, 6700, France

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Toulouse, 31059, France

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Tours, 37044, France

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Bochum, 44791, Germany

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Düsseldorf, 40225, Germany

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Erlangen, 91052, Germany

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Essen, 45147, Germany

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Frankfurt, 60590, Germany

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Hamburg, 20158, Germany

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Kiel, 24105, Germany

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Leipzig, 04103, Germany

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Magdeburg, 39120, Germany

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Mainz, D-55101, Germany

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Münster, 48149, Germany

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Nordheide, 21244, Germany

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Osnabrück, 48149, Germany

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Tübingen, 72076, Germany

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Würzburg, 97080, Germany

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Athens, 124 62, Greece

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Athens, Greece

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Thessaloniki, 54636, Greece

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Budapest, 1135, Hungary

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Ancona, 60020, Italy

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Cagliari, 09124, Italy

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Genova, 16132, Italy

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Modena, 41100, Italy

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Padua, 35100, Italy

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Pavia, 27100, Italy

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Roma, 00133, Italy

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Roma, 00168, Italy

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Roma, 00185, Italy

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Terni, 05100, Italy

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Torino, Italy

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Amsterdam, 1081 HV, Netherlands

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Amsterdam, 1105 - AZ, Netherlands

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Capelle aan den IJssel, 2906 ZC, Netherlands

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Heerlen, 6419 PC, Netherlands

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Nijmegen, 6525 GL, Netherlands

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Rotterdam, 1081 HV, Netherlands

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Utrecht, 3584 CX, Netherlands

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Voorburg, 2275 CX, Netherlands

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Bergen, 5021, Norway

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Oslo, 0407, Norway

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Stavanger, 4068, Norway

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Warsaw, 02-008, Poland

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Lisbon, 1069-166, Portugal

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Lisbon, 1169-100, Portugal

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Barcelona, 08915, Spain

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Bilbao, 48009, Spain

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Llobregat, 8907, Spain

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Madrid, 28006, Spain

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Madrid, 28007, Spain

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Madrid, 28041, Spain

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Málaga, 29010, Spain

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Valencia, 46014, Spain

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Danderyds, 182 88, Sweden

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Gothenburg, 413 45, Sweden

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Linköping, 581 85, Sweden

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Lund, 221 85, Sweden

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Stockholm, 171 76, Sweden

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Umeå, 901 85, Sweden

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Basel, 4056, Switzerland

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Bern, 3010, Switzerland

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Geneva, 1205, Switzerland

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Bornova-Izmir, 35100, Turkey (Türkiye)

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Capa-Istanbul, 34390, Turkey (Türkiye)

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Kocamustafapasa-Istanbul, 34122, Turkey (Türkiye)

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Aberdeen, AB25 1LD, United Kingdom

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Airdrie, ML6 0JS, United Kingdom

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Birmingham, United Kingdom

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Cardiff, CF14 4XW, United Kingdom

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Coventry, CV2 2DX, United Kingdom

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Dublin, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Glasgow, G11 6NT, United Kingdom

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Lancaster, LA1 4RP, United Kingdom

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Leeds, LS1 3EX, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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Liverpool, United Kingdom

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London, E11 1NR, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE1 7EH, United Kingdom

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London, W 12, United Kingdom

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Newcastle upon Tyne, NE1 4LP, United Kingdom

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Newport, United Kingdom

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Norwich, NR4 7UY, United Kingdom

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Salford, M6 8HD, United Kingdom

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Sheffield, 1OUK - S10, United Kingdom

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Suffolk, IP4 5PD, United Kingdom

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Related Publications (2)

• Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.

  PMID: 25913550 DERIVED

• Griffiths CE, Luger TA, Brault Y, Germain JM, Mallbris L. Retreatment in patients with psoriasis achieving response with etanercept after relapse due to treatment interruption: results from the CRYSTEL study. J Eur Acad Dermatol Venereol. 2015 Mar;29(3):468-73. doi: 10.1111/jdv.12585. Epub 2014 Aug 4.

  PMID: 25087839 DERIVED

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

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Italy,Greece, decresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Denmark, Finland, Sweden, Norway, MedInfoNord@wyeth.com

  PRINCIPAL INVESTIGATOR

• TRial manager

  For Belgium, trials-BEL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Austria, WPVIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Netherlands, trials-NL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Hungary, WPBUMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Turkey, Erisc@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Poland, WPWZMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Germany, MedinfoDEU@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For UK, ukmedonfo@wyeth.com

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: December 1, 2004
• Study Completion: February 1, 2007
• Last Updated: February 25, 2013
• Results First Posted: May 4, 2010

Record last verified: 2010-04

Locations

IT (11); FI (2); GR (3); CH (3); AU (3); DK (3); PT (2); SE (6); NL (8); FR (26); BE (6); HU (1); CZ (1); DE (15); ES (8); GB (22); NO (3); TU (3); PL (1)