Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

Condition(s) targeted: Moderate to Severe Psoriasis

Intervention: Etanercept (Drug); Etanercept + Acitretin (Drug); Acitretin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.

Official title: A Multicenter, Randomized, Open Pilot Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly Followed Etanercept 25mg Twice Weekly, the Combination of Etanercept 25 mg Twice Weekly and Acitretin and Acitretin Alone in Patients With Moderate to Severe Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of subjects achieving a 75% improvement from baseline in PASI score at week 24.

Secondary outcome:

Proportion of subjects achieving a 50% improvement from baseline in PASI score at each visit through week 24.

Proportion of subjects achieving a status on the Physician Global Assessment of psoriasis (PGA) of clear (0), clear/almost clear (0, 1), or clear/almost clear/mild (0, 1, 2) at each visit through week 24.

Time to PASI 50, PASI 75 and PGA of clear/almost clear/mild and PGA of clear/almost clear over 24 weeks.

Change from baseline at each visit in the PGA through 24 weeks

Change from baseline at each visit in the PASI through 24 weeks.

Change from baseline at each visit in the % BSA involvement of psoriasis through 24 weeks.

Change from baseline at each visit in the subject assessments (general health, psoriasis activity, and itching) through 24 weeks

Change from baseline at each visit in the Psoriasis Subject Satisfaction Questionnaire (PSSQ) through 24 weeks.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Active, moderate to severe psoriasis defined by the following criteria: Clinically

stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.

- In the opinion of the investigator, failure, intolerance, contraindication or not a

candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy.

- Negative urine pregnancy test before the first dose of study drug in all female

patients

Exclusion Criteria:

- Evidence of skin conditions (e. g., eczema) other than psoriasis that would interfere

with evaluations of the effect of study medication on psoriasis.

- Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout,

systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.

- Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab

(Raptiva®) and alefacept (Amevive®) is also prohibited.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Seoul 137-040, Korea, Republic of; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: July 2009
Last updated: August 31, 2010