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OpenTrials
Completed

NCT Number: NCT00111124

Enbrel® in Psoriatic Arthritis

This study is testing the effect of etanercept in treating both the skin and joint symptoms of psoriatic arthritis patients. Enbrel®, also known as etanercept, has already been approved by the Federal Food Drug Administration for the treatment of psoriatic arthritis. It is taken as an injection under the skin. Participants in the trial will be offered etanercept free of charge to be self-injected once weekly for 24 weeks. During that period they will have 5 appointments at the study center and will also be asked to complete assessments of their health.

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Key information

Conditions

Psoriasis Arthritis Joint Diseases Musculoskeletal Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Individuals may be eligible to enroll in this study if they suffer from psoriasis (covering at least 10% of the body), and: - have had two or more swollen, tender or painful joints for at least 3 months or: - have lower back pain which your physician has diagnosed as sacroiliitis or spondylitis in one or more joints or: - have been diagnosed with active psoriatic arthritis

Treatment and study plan

Enbrel®

Drug

Primary outcomes

  1. The proportion of subjects achieving a status on the Physician Global Assessment of Psoriasis of ""mild"" or better at week 24.

Secondary outcomes

  1. Quality of life and disability as measured by the DLQI and HAQ

  2. Financial impact of therapy on disease as measured by Patient Pharmacoeconomic Questionnaire

  3. Serious Adverse Events

  4. Patient Global Assessment of Psoriasis

  5. Patient Global Assessment of Joint Disease

  6. Patient Global Assessment of Joint Pain

  7. Patient Assessment of Morning Stiffness Duration

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

First posted
May 18, 2005
Registry last updated
May 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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