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Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis

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ClinicalTrials.gov Identifier: NCT00111449
Recruitment Status : Completed
First Posted : May 23, 2005
Last Update Posted : May 15, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Etanercept Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis
Study Start Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

Secondary Outcome Measures :
  1. Dermatology Live Quality Index (DLQI) response at week 12
  2. Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
  3. Psoriasis pain (VAS) at week 12
  4. Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
  5. PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
  6. Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
  7. Adverse events, infections injection site reactions during long-term therapy
  8. Serious adverse events and infections during long-term therapy
  9. Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111449

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: MD Amgen
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00111449     History of Changes
Other Study ID Numbers: 20030117
First Posted: May 23, 2005    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by Amgen:
Psoriasis, adults
skin, Phase 3
clinical trial, Amgen
etanercept, Enbrel®
moderate, severe

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors