Working... Menu

Enbrel® in Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111124
Recruitment Status : Completed
First Posted : May 18, 2005
Last Update Posted : May 15, 2013
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Enbrel® Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Enbrel® in Psoriatic Arthritis

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

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 identifier (NCT number): NCT00111124

Sponsors and Collaborators
Layout table for investigator information
Study Director: MD Amgen

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Amgen Identifier: NCT00111124     History of Changes
Other Study ID Numbers: 20030106
First Posted: May 18, 2005    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by Amgen:

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spinal Diseases
Bone 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