Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis - Full Text View

Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis (PRISTINE-)

This study is ongoing, but not recruiting participants.

First Received: April 17, 2008 Last Updated: September 30, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00663052

Purpose

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.

Condition	Intervention	Phase
Plaque Psoriasis Psoriasis	Drug: Etanercept	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Change in PASI Scores from at Week 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of Etanercept on the QoL of each Treatment Group. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	May 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental A	Drug: Etanercept
Group B: Experimental B	Drug: Etanercept

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

18 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.

Exclusion Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663052

Hide Study Locations

Locations

Argentina

Provincia de Buenos Aires, Argentina, CP 1114

Provincia de Buenos Aires, Argentina, CP 1199

El Palomar, Buenos Aires, Argentina, CP 1663
Austria

Feldkirch, Austria, A-6800

Wein, Austria, A-1030
Belgium

Gent, Belgium, 9000

Brussels, Belgium, 1200
Czech Republic

Pilsen, Czech Republic, 305 99

Jihlava, Czech Republic, 586 33
Germany

Frankfort/Main, Germany, D-60950

Hamburg, Germany, D-202046

Muenchen, Germany, 80802

Gudrunstr, Germany, 44791

Erlangen, Germany, 91052

Kiel, Germany, D-24105
Greece

Athens, Greece, 16121
Hungary

Debrecen, Hungary, H-4012

Miskolc, Hungary, H-3529
Italy

L'Aquila, Italy, 67100
Korea, Republic of

Seoul, Korea, Republic of, 135-710

Seoul, Korea, Republic of, 110-744
Mexico

Zapopan, Mexico, 45190

Monterrey, Mexico, 64710

Monerey, Mexico, 64020
Spain

Barcelona, Spain, 08025

Valencia, Spain, 46014

Santiago de Compostela, Spain, 15706
Taiwan

Taipei, Taiwan, 100

Taipei City, Taiwan, 110
Thailand

Bangkok, Thailand, 10330

Bangkok, Thailand, 10400

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A6-4425
Study First Received:	April 17, 2008
Last Updated:	September 30, 2009
ClinicalTrials.gov Identifier:	NCT00663052 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Austria: Federal Ministry for Health and Women; Czech Republic: State Institute for Drug Control; European Union: European Medicines Agency; Hungary: National Institute of Pharmacy; Korea: Food and Drug Administration

Keywords provided by Wyeth:

Enbrel, Psoriasis, Topical Psoriasis
Wyeth Psoriasis
Active Psoriasis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Psoriasis

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 27, 2009