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

Last updated on May 10, 2018

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Study Location
Contact
1-800-718-1021
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

Exclusion criteria
The factors, or reasons, that prevent a person from participating 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

NCT00581165
Pfizer
Completed
Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept

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Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept
Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Psoriasis
Drug: Etanercept
recommended dose of enbrel is 25mg administered twice weekly.
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
August 2007
August 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00581165
0881A1-101781
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinial Trials Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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