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Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581165
First Posted: December 27, 2007
Last Update Posted: December 27, 2007
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.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain; (ii) the incidence of adverse events reported in these patients, and (iii) the role that age and concomitant therapy might play in the development of adverse reactions.

Condition Intervention Phase
Psoriasis Drug: Etanercept Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Reduction and/or withdrawal of systemic therapies, Proportion of patients with plaque psoriasis achieving PASI 50, 75 and 90 at each evaluation and BSA at each evaluation [ Time Frame: 18 months ]

Enrollment: 500
Study Start Date: February 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Etanercept
    recommended dose of enbrel is 25mg administered twice weekly.
  Eligibility

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
Criteria

Inclusion Criteria:

  1. Informed consent signed by patients prior to study entry
  2. 18 years of age or older at screening visit
  3. Patients with moderate to severe psoriasis
  4. Patients who have failed conventional systemic treatment
  5. Patients who have a contraindication to conventional systemic therapy
  6. Patients who are intolerant to conventional systemic therapy
  7. A negative serum pregnancy test at screening in women of childbearing potential
  8. Able to self-inject study drug or have a designee who can do so
  9. In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol
  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): NCT00581165


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: Wyeth (Registry Contact: Clinial Trials Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581165     History of Changes
Other Study ID Numbers: 0881A1-101781
First Submitted: December 21, 2007
First Posted: December 27, 2007
Last Update Posted: December 27, 2007
Last Verified: December 2007

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