Clinical trial NCT00936065: Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate to Severe Psoriasis
Keywords: Etanercept
Acitretin
Psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
timeFrame: Weeks 2, 4, 8, 12, 18, and 24
measure: Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Time to Achieve a PASI 50 Score
timeFrame: Baseline up to Week 24
measure: Time to Achieve a PASI 75 Score
timeFrame: Baseline up to Week 24
measure: Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
timeFrame: Baseline up to Week 24
measure: Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear
timeFrame: Baseline up to Week 24
measure: Change From Baseline in the PGA of Psoriasis
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18, and 24
measure: Change From Baseline in the PASI Score
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12 ,18 and 24
measure: Change From Baseline in SGA of Itching at Each Visit
timeFrame: Baseline, Weeks 2, 4, 8, 12 ,18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
measure: Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Korea
city: Gyeonggido
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Korea
city: S0
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Lee JH, Youn JI, Kim TY, Choi JH, Park CJ, Choe YB, Song HJ, Kim NI, Kim KJ, Lee JH, Yoo HJ. A multicenter, randomized, open-label pilot trial assessing the efficacy and safety of etanercept 50 mg twice weekly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone in patients with moderate to severe psoriasis. BMC Dermatol. 2016 Jul 25;16(1):11. doi: 10.1186/s12895-016-0048-z.