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Enbrel® in Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00111124
First received: May 17, 2005
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Psoriasis
Drug: Enbrel®
Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Enbrel® in Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by Amgen:

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

Secondary Outcome Measures:
  • Quality of life and disability as measured by the DLQI and HAQ
  • Financial impact of therapy on disease as measured by Patient Pharmacoeconomic Questionnaire
  • Serious Adverse Events
  • Patient Global Assessment of Psoriasis
  • Patient Global Assessment of Joint Disease
  • Patient Global Assessment of Joint Pain
  • Patient Assessment of Morning Stiffness Duration

  Eligibility

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

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111124

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00111124     History of Changes
Other Study ID Numbers: 20030106
Study First Received: May 17, 2005
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
psoriasis
arthritis
Enbrel®
etanercept

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Psoriasis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014