Safety and Efficacy of Etanercept in Patients With Psoriasis

NCT02258282 | Unknown DMC

• 1 other identifier: YSP20140688
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks

  At 0 week, 12 weeks, 24 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

Etanercept

EXPERIMENTAL

Patients under the treatment of 50 mg Etanercept

Drug: Etanercept

Control

SHAM COMPARATOR

Patients under the treatment of traditional DMARDs

Drug: Control

Interventions

Etanercept DRUG

Etanercept

Control DRUG

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has plaque psoriasis and has shown an unsatisfactory response to traditional DMARDs
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu PLA General Hospital: lead

Study Sites (1)

General Hospital of Chengdu Military Area Command PLA

Chengdu, Sichuan, 610083, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 7, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

CN (1)