Safety and Efficacy of Etanercept in Patients With Psoriasis

Chengdu PLA General Hospital

Status

Unknown

Conditions

Psoriasis

Treatments

Drug: Etanercept

Drug: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT02258282

YSP20140688

Details and patient eligibility

About

The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to traditional DMARDs.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

has plaque psoriasis and has shown an unsatisfactory response to traditional DMARDs
18 to 75 years old
has PGA of 3 or more at Day 0
has BSA of 3% or more at Day 0
has psoriasis severe enough to be eligible to systemic therapy
willing to use an effective method of contraception for at least 30 days before Day 0 and until at least 1 month after the last drug administration;
capable of giving informed consent
with normal or non clinically significant chest X-ray within 6 months prior to Day 0
with negative Purified Protein Derivative (PPD) or Quantiferon TB Gold test within 90 days prior to Day 0
female patients of childbearing potential have a negative serum pregnancy test
patient is able to start etanercept per the approved product monograph

Exclusion criteria

has used topical steroids, topical tar preparations, or other anti-psoriatic preparations within the two weeks prior to Day 0 or during the study period
has presence of erythrodermic, pustular or guttate psoriasis
has had significant infections within the 30 days prior to Day 0
has received investigational drugs within the four weeks prior to screening or during the study period
has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy or methotrexate within the four weeks prior to Day 0 or during the study period
received systemic antibiotics within the four weeks prior to Day 0
has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0 or during the study period
has used infliximab within 14 days of Day 0 or during the study period
has used other biologic agents for the treatment of psoriasis besides etanercept 8 weeks prior to Day 0 or during the study period
has had an allergic reaction to infliximab
has an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient
uncontrolled or severe comorbidities such as poorly controlled diabetes mellitus, NYHA class III or IV heart failure, history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris
uncontrolled hypertension, oxygen-dependent severe pulmonary disease
has a known sero-positivity for HIV virus or history of any other immunosuppressive disease
has active or chronic Hepatitis B or C
has any mycobacterial disease, patient with a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication
has a known hypersensitivity to etanercept or one of its components
has received a live attenuated vaccine within the 12 weeks prior to Day 0 or plans to receive one during the study
current pregnancy or lactation