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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Moderate to Severe Psoriasis

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

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

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

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.

Clinical Details

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: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24

Secondary outcome:

Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score

Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear

Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear

Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild

Time to Achieve a PASI 50 Score

Time to Achieve a PASI 75 Score

Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild

Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear

Change From Baseline in the PGA of Psoriasis

Change From Baseline in the PASI Score

Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24

Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24

Change From Baseline in SGA of Itching at Each Visit

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24

Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24

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

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

Eligibility

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.

Locations and Contacts

Pfizer Investigational Site, Seoul 431-070, Korea, Republic of

Pfizer Investigational Site, Seoul 135 710, Korea, Republic of

Pfizer Investigational Site, Seoul 138 736, Korea, Republic of

Pfizer Investigational Site, Daejeon, Korea 301 721, Korea, Republic of

Pfizer Investigational Site, Gyeonggido, Korea 420 717, Korea, Republic of

Pfizer Investigational Site, Seoul, Korea 130 702, Korea, Republic of

Pfizer Investigational Site, Seoul, Korea 137 701, Korea, Republic of

Pfizer Investigational Site, Seoul, Korea 152 703, Korea, Republic of

Pfizer Investigational Site, Seoul, Korea 110 744, Korea, Republic of

Pfizer Investigational Site, S0, Seoul 137-701, Korea, Republic of

Additional Information

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

Starting date: July 2009
Last updated: March 12, 2012

Page last updated: August 23, 2015

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