Safety and Efficacy of Etanercept in Patients With Psoriasis

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.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Etanercept; Drug: Control

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610083
      • General Hospital of Chengdu Military Area Command PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etanercept; Patients under the treatment of 50 mg Etanercept	Drug: Etanercept
Sham Comparator: Control; Patients under the treatment of traditional DMARDs	Drug: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks	At 0 week, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean Body Surface Area (BSA)	At 0 week, 12 weeks, 24 weeks
Mean Psoriasis Area and Severity Index (PASI)	At 0 week, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Chengdu PLA General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 3, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 7, 2014

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: YSP20140688