Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept
Phase 4
Completed
- Conditions
- Psoriasis
- Registration Number
- NCT00581165
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- Informed consent signed by patients prior to study entry
- 18 years of age or older at screening visit
- Patients with moderate to severe psoriasis
- Patients who have failed conventional systemic treatment
- Patients who have a contraindication to conventional systemic therapy
- Patients who are intolerant to conventional systemic therapy
- A negative serum pregnancy test at screening in women of childbearing potential
- Able to self-inject study drug or have a designee who can do so
- In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment 18 months
- Secondary Outcome Measures
Name Time Method 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 18 months