|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00333034 |
|
Date of registration:
|
23/05/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis
|
|
Scientific title:
|
A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis |
|
Date of first enrolment:
|
June 2006 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00333034 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Austria
|
Belgium
|
France
|
Germany
|
Hungary
|
Italy
|
Netherlands
|
Poland
|
|
Romania
|
Spain
| | | | | | |
|
Contacts
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Romania, WVPIMED@wyeth.com |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Austria, medinfo@wyeth.com |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Belguim, trials-BEL@wyeth.com |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Spain, infomed@wyeth.com |
|
|
Name:
|
Medical Monitor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Wyeth is now a wholly owned subsidiary of Pfizer |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Poland, WPWZMED@wyeth.com |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Germany, medinfoDEU@wyeth.com |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Netherlands, trials-NL@wyeth.com |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For France, infomedfrance@wyeth.com |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Italy, descresg@wyeth.com |
|
|
Name:
|
Trial Manager |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
For Hungary, WPBUMED@wyeth.com |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria: -Adults greater than or equal to 18 years of age with clinically
stable plaque psoriasis involving greater than or equal to 10% of the body surface and a
minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to
respond to, or have a contraindication to, or intolerant to at least 1 of the following
systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX),
Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and
Ultraviolet A (PUVA), Fumarate Exclusion Criteria: -Previous treatment with etanercept,
antibody to TNF or other TNF inhibitors. -Active guttate, erythrodermic, or pustular
psoriasis at the time of the screening or baseline.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Psoriasis
|
|
Intervention(s)
|
|
Drug: Etanercept
|
|
Primary Outcome(s)
|
|
The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline.
|
|
Secondary Outcome(s)
|
|
EQ5D, FACIT-F.
|
|
The secondary efficacy endpoints will include but not limited to: PASI 50, PASI 75 (at visit other than week 12, PASI 90, PASI score PGA of 0 or 1 (clear or minimal, Patient global assessment of psoriasis, DLQI,
|
|
Secondary ID(s)
|
|
0881A6-318
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|