NCT02258282.

Study name	Safety and efficacy of etanercept in patients with psoriasis
Methods	RCT, placebo‐controlled, double‐blind trial Date of study: May 2014 Location: China Phase 4
Participants	Randomised: 80 participants Inclusion criteria Has plaque psoriasis and has shown an unsatisfactory response to traditional disease‐modifying antirheumatic drugs (DMARDs) 18 ‐ 75 years old PGA ≥ 3 at Day 0 BSA ≥ 3% at Day 0 Has psoriasis severe enough to be eligible for systemic therapy Willing to use an effective method of contraception for ≥ 30 days before day 0 and until ≥ 1 month after the last drug administration Capable of giving informed consent Normal or non‐clinically significant chest X‐ray within 6 months prior to day 0 Negative Purified Protein Derivative (PPD) or Quantiferon TB Gold test within 90 days prior to day 0 Women of childbearing potential have a negative serum pregnancy test Able to start etanercept per the approved product monograph Exclusion criteria Used topical steroids, topical tar preparations, or other anti‐psoriatic preparations within the 2 weeks prior to day 0 or during the study period Presence of erythrodermic, pustular or guttate psoriasis Significant infections within the 30 days prior to day 0 Received investigational drugs within the 4 weeks prior to screening or during the study period Treated with systemic anti‐psoriatic drugs such as steroids, retinoids, ciclosporin, PUVA therapy or methotrexate within the 4 weeks prior to day 0 or during the study period Received systemic antibiotics within the 4 weeks prior to day 0 Treated with UV light therapy (UVB, nbUVB) within the 2 weeks prior to day 0 or during the study period Used infliximab within 14 days of day 0 or during the study period Used other biologic agents for the treatment of psoriasis besides etanercept 8 weeks prior to day 0 or during the study period Had an allergic reaction to infliximab 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 participant Uncontrolled or severe comorbidities such as poorly‐controlled diabetes mellitus, NYHA (New York Heart Association) class III or IV heart failure, history of myocardial infarction or cerebrovascular accident or transient ischaemic attack within 3 months of screening visit; unstable angina pectoris Uncontrolled hypertension, oxygen‐dependent severe pulmonary disease Known sero‐positivity for HIV virus or history of any other immunosuppressive disease Active or chronic Hepatitis B or C Any mycobacterial disease, patient with a chest X‐ray suggestive of TB or taking anti‐TB medication Known hypersensitivity to etanercept or one of its components Received a live attenuated vaccine within the 12 weeks prior to day 0 or plans to receive 1 during the study Current pregnancy or lactation
Interventions	Intervention Etanercept (participants under the treatment of 50 mg etanercept) Control intervention Placebo
Outcomes	At week 24 Primary outcome PGA Secondary outcomes PASI BSA
Starting date	Study start date: May 2014 Estimated primary completion date: December 2022 Last update posted: April 2017, active, not recruiting
Contact information	Yang Min, Ph.D, Chengdu PLA General Hospital
Notes	On ClinicalTrials.gov Ongoing study