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

Psoriasis Clinical Trial

Official title:

Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581165
• Other study ID #: 0881A1-101781
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2007
• Last updated: December 26, 2007
• Start date: February 2006
• Est. completion date: August 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Ethics CommitteeSpain: Ministry of HealthSpain: Ministry of Health and ConsumptionSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Etanercept
recommended dose of enbrel is 25mg administered twice weekly.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment		18 months	Yes
Secondary	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	Yes