The purpose of this study is to evaluate the efficacy and safety of etanercept 50 mg twice
weekly followed by etanercept 25mg twice weekly, as compared with the combination of
etanercept 25 mg twice weekly and acitretin and acitretin alone in patients with moderate to
severe psoriasis in Korea
Inclusion Criteria:
1. 18 years of age or older at time of consent.
2. Active, moderate to severe psoriasis defined by the following criteria: Clinically
stable, plaque psoriasis involving 10% body surface area (BSA) or PASI 10.
3. 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.
4. Negative urine pregnancy test before the first dose of study drug in all female
patients (except those surgically sterile or postmenopausal of at least 3 years).
Sexually active women of childbearing potential must use a medically accepted form of
contraception, which include oral contraception, injectable or implantable methods,
intrauterine devices, or properly used barrier contraception during the study and for
3 years after last dose of acitretin.
5. Able to self-inject test article or have a designee who can do so.
6. Able to store injectable test article under refrigerated conditions.
7. Able to complete health outcome assessments and any study diaries.
8. Subject meets local therapeutic guidelines for use of anti- TNF agent with regards to
TB.
Exclusion Criteria
1. Evidence of skin conditions (e. g., eczema) other than psoriasis that would interfere
with evaluations of the effect of study medication on psoriasis.
2. Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout,
systemic lupus erythematous, systemic vasculitis, scleroderma, polymyositis, or
associated syndromes.
3. Any TNF inhibitors including ETN, or other biologic agents within 24 weeks before
baseline visit. Prior exposure to efalizumab (Raptiva®), alefacept (Amevive®) and
ustekinumab is also prohibited.
4. Sunbathing and other sun or ultraviolet radiation (UV) treatment for therapeutic
reasons is prohibited from 28 days before baseline visit through week 24 of the
study.
5. UV treatment for therapeutic reasons PUVA or ultraviolet B radiation (UVB) therapy
(including narrow band UVB and excimer laser) within 28 days of the baseline visit.
6. Abnormal hematology or blood chemistry profile:
i. hemoglobin < 85 g/L; ii. hematocrit < 27%; iii. platelet count < 125 x109/L; iv.
white blood cell count < 3. 5 x109/L; v. serum creatinine (Creat) > 175 µmol/L; vi.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >2 times the
laboratory's upper limit of normal.
7. Known contraindication or hypersensitivity to etanercept or their excipients or to
acitretin
8. Pregnant or breast-feeding women
9. Subject has any clinical relevant concurrent medical conditions, including:
- Serious infection (infection associated with hospitalization and/or intravenous
antibiotics) within 1 month before test article administration or active
infection at screening, including known human immunodeficiency virus (HIV)
infection.
- Active or recent (within 2 years) tuberculosis (TB) infection (Note: Local
country guidelines should be followed for appropriate screening and prophylaxis
in the setting of anti-TNF therapy including a minimum of chest radiograph and
objective TB testing such as PPD and Quantiferon, and the final decision for
anti-TB treatment will follow Quantiferon). Subjects with latent TB infection
may be allowed for prophylactic therapy and if treatment is initiated before
therapy, followed by proof that no adverse drug reaction has occurred with the
anti-TB medications.
- - Presence or history of cancer (or carcinoma in situ) other than resected
cutaneous basal cell or squamous cell carcinoma within the past 5 years
before the screening visit.
- Positive testing history for hepatitis B surface antigen (HBsAg) or
hepatitis C virus (HCV) antibody at the screening visit or known history
and presence of hepatitis B or hepatitis C infection.
- Uncontrolled hypertension (defined as screening systolic blood pressure>160
mmHg or screening diastolic blood pressure>100mmHg).
- Myocardial infarction within 12 months of the screening visit.
- Unstable angina pectoris within 6 months of screening visit.
- Class Ⅲ or Ⅳ congestive heart failure as defined by the New York Heart
Association
- Severe pulmonary disease requiring hospitalization or supplemental oxygen
within 12 months of screening.
- Diagnosis of multiple sclerosis or other central or peripheral
demyelinating diseases.
- Presence or history of confirmed blood dyscrasias.
- Insulin-dependent diabetes mellitus.
- Open cutaneous ulcers.
- Any condition that, in the investigator's judgement, might cause this study
to be detrimental to the subject.
10. Received isoniazid (INH) therapy during screening and has had the mandatory liver
function test (LFT) profile before the baseline visit that is out of 2 times the
laboratory's upper limit of the normal lab range. (Note: the LFT profile labs must be
drawn after initiating INH therapy at a minimum of 3 weeks and at least 2 days prior
to the planned baseline visit).
11. Received any investigational drug within 3 months of screening visit.
12. Reasonable expectation that the subjects will not be able to satisfactorily complete
the study.
