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CompletedNCT00581165Updated Dec 27, 2007

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

A Phase 4 interventional study of Etanercept in Psoriasis, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-12-27.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 500 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

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Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (actual)

Interventions

  • DrugEtanercept

    recommended dose of enbrel is 25mg administered twice weekly.

06

What researchers measure

Primary outcomes

  1. Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment

    Time frame: 18 months

Secondary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00581165
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Dec 27, 2007
Start date
Feb 2006
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Dec 27, 2007

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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