Randomized Open-label Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept Treatment

Phase 1

• Conditions: Plaque psoriasis; MedDRA version: 12.0Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2008-004439-39-FR
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-23
• Study Completion: 2013-04-23
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 298

Inclusion Criteria

1. 18 years of age or older at time of consent
2. Previously treated with ETN for chronic plaque psoriasis for at least 20 weeks
prior to the screening visit, who are documented to have been on a total weekly
dose of 50mg per week for at least the 6 weeks preceding the day of the
screening visit and who have shown clinical response with a PGA inferior or equal
to 1 at the screening visit
3. Having shown clinical response with a PGA inferior or equal to 1 at the screening
visit
4. With a PGA inferior or equal to 1 at the baseline visit
5. Where the last injection of ETN was performed not more than 7 days before the
baseline visit
6. Able to store the injectable investigational product under refrigerated conditions
7. Able to self-inject investigational product or have a designee who can do so
8. Able to complete health outcome assessments and any study diaries.
9. Demonstrates an adequate screening for tuberculosis (TB) in accordance with
local country guidelines, since ETN has been prescribed, tests results and/or
radiographic report must be available at site
10. Is a man or woman who is surgically sterile or is at least 1 year postmenopausal.
A woman not surgically sterile or at least 1 year postmenopausal must
demonstrate a negative serum pregnancy test at screening and a negative
urine pregnancy test at baseline, and must agree and commit to use medically
acceptable forms of contraception.

All female subjects who are also taking known teratogens, eg methotrexate, acitretin, must agree and commit to use contraceptive precautions as recommended by the respective SPCs, data sheets or equivalent legal documents. In addition, all male subjects taking concomitant methotrexate who are biologically capable of
having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of methotrexate.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Evidence of skin conditions (eg eczema) other than psoriasis that would interfere
with evaluations of the effect of study medication on psoriasis
2. Evidence of active or previously known medical history of inflammatory arthritis
3. Any biologics other than ETN within the 20 weeks prior to the screening visit
4. Ciclosporin, within 28 days of the baseline visit
5. Received isoniazid (INH) therapy during screening and has had the mandatory
liver function test (LFT) before the baseline visit that is out of the normal lab
range.
6. Receipt of any live (attenuated) vaccine within 4 weeks before baseline.
7. Sunbathing or UV treatment for therapeutic reasons (ultraviolet light A [UVA],
psoralen and ultraviolet light A therapy [PUVA], or ultraviolet light B [UVB] therapy,
including narrow band UVB and excimer laser) within 28 days of the baseline visit.
8. Oral, intravenous, intramuscular, intraarticular and subcutaneous (SC)
corticosteroids within 28 days of the baseline visit. Exception: inhaled
corticosteroids for the treatment of pulmonary conditions and topical ophthalmic
solutions containing corticosteroids with or without antibiotics for episodes of
acute ocular inflammation are permitted.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the effect on subjects in whom psoriasis has responded to initial treatment with etanercept (ETN) of two different strategies for managing a good response or complete response (PGA= 1 or 0) over a 52 week period..;Secondary Objective: • To compare the efficacy of the 2 different strategies by reference to quality of life measure over the duration of the study<br>• To explore the time course of severity following treatment modification<br>• To explore the degree of subject satisfaction with the two different options for management following successful initial treatment<br>;Primary end point(s): The primary efficacy endpoint is the average 52 week PGA (measured as the time-normalized area under curve)