Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

NCT00663052 | Completed Phase 4 Results

• 2 other identifiers: 0881A6-4425B1801013
• Study Type: interventional
• Target: 273
• Locations: 13 countries
• Sites: 38

Brief Summary

The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.

Conditions

Plaque Psoriasis; Psoriasis

Keywords

Enbrel; Psoriasis; Topical Psoriasis; Wyeth Psoriasis; Active Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24

  PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

  Week 24

Secondary Outcomes (16)

• Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24

  Baseline to Week 24

• Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24

  Baseline to Week 24

• Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24

  Baseline to week 24

• Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24

  Baseline to Week 24

• Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24

  Baseline to Week 24

Other Outcomes (21)

• Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24

  Baseline to Week 24

• Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24

  Baseline to Week 24

• Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24

  Baseline to Week 24

Study Arms (2)

Group A

EXPERIMENTAL

A

Drug: Etanercept

Group B

EXPERIMENTAL

B

Drug: Etanercept

Interventions

Etanercept DRUG

ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.

Group A

Eligibility Criteria

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

You may qualify if:

• years of age or older at time of consent.
• Active, moderate to severe chronic plaque psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (BSA) or PASI greater than or equal to 10.
• In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus ultraviolet A radiation (PUVA) therapy.

You may not qualify if:

• Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
• Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
• Active or recent (within 2 years) tuberculosis (TB) infection.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (38)

Pfizer Investigational Site

Capital Federal, Buenos Aires, 01114, Argentina

Location

Pfizer Investigational Site

Capital Federal, Buenos Aires, 01199, Argentina

Location

Pfizer Investigational Site

San Miguel, Buenos Aires, 1684, Argentina

Location

Pfizer Investigational Site

Feldkirch, Austria

Location

Pfizer Investigational Site

Vienna, 1030, Austria

Location

Pfizer Investigational Site

Brussels, Belgium, B-1200, Belgium

Location

Pfizer Investigational Site

Ghent, 9000, Belgium

Location

Pfizer Investigational Site

Liège, 4020, Belgium

Location

Pfizer Investigational Site

Jihlava, 586 33, Czechia

Location

Pfizer Investigational Site

Ostrava- Poruba, 708 00, Czechia

Location

Pfizer Investigational Site

Plzen-Bory, 305 99, Czechia

Location

Pfizer Investigational Site

Bochum, 44791, Germany

Location

Pfizer Investigational Site

Erlangen, 91052, Germany

Location

Pfizer Investigational Site

Frankfurt am Main, 60590, Germany

Location

Pfizer Investigational Site

Hamburg, 20246, Germany

Location

Pfizer Investigational Site

Kiel, 24105, Germany

Location

Pfizer Investigational Site

München, 80802, Germany

Location

Pfizer Investigational Site

Osnabrück, 49078, Germany

Location

Pfizer Investigational Site

Athens, 124 62, Greece

Location

Pfizer Investigational Site

Athens, 16121, Greece

Location

Pfizer Investigational Site

Budapest, 1085, Hungary

Location

Pfizer Investigational Site

Debrecen, 4012, Hungary

Location

Pfizer Investigational Site

Miskolc, 3529, Hungary

Location

Pfizer Investigational Site

Szeged, 6720, Hungary

Location

Pfizer Investigational Site

Catanzaro, 88110, Italy

Location

Pfizer Investigational Site

L’Aquila, 67100, Italy

Location

Pfizer Investigational Site

Zapopan, Jalisco, 45190, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo Leon / Mexico, 64020, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64710, Mexico

Location

Pfizer Investigational Site

Gangnam-gu, 135-710, South Korea

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08025, Spain

Location

Pfizer Investigational Site

Santiago de Compostela, La Coruña, 15706, Spain

Location

Pfizer Investigational Site

Fuenlabrada, Madrid, 28942, Spain

Location

Pfizer Investigational Site

Valencia, 46014, Spain

Location

Pfizer Investigational Site

Taipei, 110, Taiwan

Location

Pfizer Investigational Site

Taipei TOC, 100, Taiwan

Location

Pfizer Investigational Site

Bangkok, Thailand

Location

Related Publications (2)

• Kemeny L, Amaya M, Cetkovska P, Rajatanavin N, Lee WR, Szumski A, Marshall L, Mahgoub EY, Aldinc E. Effect of etanercept therapy on psoriasis symptoms in patients from Latin America, Central Europe, and Asia: a subset analysis of the PRISTINE trial. BMC Dermatol. 2015 May 21;15:9. doi: 10.1186/s12895-015-0028-8.

  PMID: 25994179 DERIVED

• 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

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Wyeth, 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 23, 2012
• Results First Posted: April 23, 2012

Record last verified: 2012-03

Locations

BE (3); AR (3); GR (2); ME (3); TW (2); TH (1); AU (2); KR (2); ES (4); HU (4); CZ (3); DE (7); IT (2)