Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis

NCT00333034 | Completed Phase 3

• 1 other identifier: 0881A6-318
• Study Type: interventional
• Target: 120
• Locations: 10 countries
• Sites: 23

Brief Summary

The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline.

Secondary Outcomes (2)

• The secondary efficacy endpoints will include but not limited to: PASI 50, PASI 75 (at visit other than week 12, PASI 90, PASI score PGA of 0 or 1 (clear or minimal, Patient global assessment of psoriasis, DLQI,

• EQ5D, FACIT-F.

Interventions

Etanercept DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

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

Study Sites (23)

Unknown Facility

Innsbruck, 6020, Austria

Location

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Brussels, 1070, Belgium

Location

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Leuven, 3000, Belgium

Location

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Paris, 75010, France

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Paris, 75018, France

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Bonn, 53105, Germany

Location

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Hamburg, 20354, Germany

Location

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München, 80335, Germany

Location

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Münster, 48149, Germany

Location

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Regensburg, 93053, Germany

Location

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Miskolc, 3501, Hungary

Location

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Szolnok, 5400, Hungary

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Messina, 98158, Italy

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Novara, 28100, Italy

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Drachten, 9202 NN, Netherlands

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Nijmegen, 6525, Netherlands

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Lodz, 91-347, Poland

Location

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Wroclaw, 50-368, Poland

Location

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Bucharest, 11461, Romania

Location

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Cluj-Napoca, 400006, Romania

Location

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A Coruña, 15006, Spain

Location

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Madrid, 28922, Spain

Location

Unknown Facility

Seville, 41003, Spain

Location

Related Publications (1)

• 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

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

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Austria, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Belguim, trials-BEL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For France, infomedfrance@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Germany, medinfoDEU@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Hungary, WPBUMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Italy, descresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Netherlands, trials-NL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Poland, WPWZMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Romania, WVPIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Spain, infomed@wyeth.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 23, 2006
• First Posted: June 2, 2006
• Study Start: June 1, 2006
• Study Completion: May 1, 2007
• Last Updated: December 6, 2007

Record last verified: 2007-12

Locations

FR (2); AU (1); DE (5); PL (2); IT (2); HU (2); RO (2); ES (3); BE (2); NL (2)