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

NCT00581165

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept
Official Title  ICMJE Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: Etanercept
recommended dose of enbrel is 25mg administered twice weekly.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2007)
500
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00581165
Other Study ID Numbers  ICMJE 0881A1-101781
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinial Trials Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP