Back to resultsOptimizing Psoriasis Treatment of Etanercept Combined Methotrexate
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
etanercept combined with methotrexate or etanercept combined with placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Adults of both sexes, at least 18 years of age
- have stable plaque psoriasis for at least 6 months, psoriasis involving at least 10 percent of the body surface area, had a minimal PASI of 10 at screening
- had previously received phototherapy or systemic psoriasis therapy at least once or candidates for such therapy in the opinion of the investigator
Exclusion Criteria:
- Patients with guttate, erythrodermic, or pustular psoriasis at the time of screening
- recent infection or opportunistic infections, active tuberculosis, hepatitis B and so on
- liver and kidney dysfunction
- those with other serious, progressive, uncontrolled disorders of vital organs and systems (including cardiovascular, liver, lung and kidney), other autoimmune diseases, cancer, HIV infection, which are not suitable for participation in the study of the disease
- history of significant methotrexate toxicity or total cumulative methotrexate exposure > 1000 mg (unless grade ‡ IIIb liver injury has not occurred)
- use of ultraviolet (UV) B therapy, topical ciclosporin or calcineurin inhibitors, class III through VII topical corticosteroids (permitted on the scalp, axillae, and ⁄or groin), or topical vitamin A or D analogues within 14 days of screening
- and psoralen or UVA therapy, systemic psoriasis therapy (including methotrexate), oral retinoids, class I or II topical corticosteroids, dithranol, cyclophosphamide, sulfasalazine, or intravenous or oral calcineurin inhibitors within 28 days of screening
- Patients were excluded if they had received a tumor necrosis factor (TNF) blocking agent or other biologics within 3 months or interleukin (IL)-12 or IL-23 inhibitors within 6 months of study initiation
Sites / Locations
- the 2Nd Affiliated Hospital,Zhejiang University,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
etanercept combined with methotrexate
etanercept as monotherapy
Arm Description
patients treated with etanercept combined with methotrexate
patients treated with etanercept combined with placebo
Outcomes
Primary Outcome Measures
psoriasis area and severity index 75(PASI75)
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)
Secondary Outcome Measures
psoriasis area and severity index 50(pasi 50)
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI50 (a patient that has an improvement from baseline PASI of at least 50%)
psoriasis area and severity index 90(pasi 90)
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI90 (a patient that has an improvement from baseline PASI of at least 90%)
Dermatology Life Quality Index (DLQI) change
Change from baseline in plaque psoriasis as assessed by DLQI (dermatology life quality index ) response
adverse events(AEs)
Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
Full Information
NCT ID
NCT02313922
First Posted
December 8, 2014
Last Updated
August 16, 2018
Sponsor
Zhejiang University
Collaborators
Shanghai CP Guojian Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02313922
Brief Title
Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate
Official Title
Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate: a Phase IV, Multicenter, Randomized, Double-blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Shanghai CP Guojian Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether etanercept combined with methotrexate are superiority than etanercept as monotherapy in the treatment of chinese severe plaque psoriasis. A phase IV, multicenter, randomized, double-blind, controlled trial was conducted.The primary outcome was Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
466 (Actual)
8. Arms, Groups, and Interventions
Arm Title
etanercept combined with methotrexate
Arm Type
Experimental
Arm Description
patients treated with etanercept combined with methotrexate
Arm Title
etanercept as monotherapy
Arm Type
Experimental
Arm Description
patients treated with etanercept combined with placebo
Intervention Type
Drug
Intervention Name(s)
etanercept combined with methotrexate or etanercept combined with placebo
Primary Outcome Measure Information:
Title
psoriasis area and severity index 75(PASI75)
Description
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
psoriasis area and severity index 50(pasi 50)
Description
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI50 (a patient that has an improvement from baseline PASI of at least 50%)
Time Frame
24 weeks
Title
psoriasis area and severity index 90(pasi 90)
Description
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI90 (a patient that has an improvement from baseline PASI of at least 90%)
Time Frame
24 weeks
Title
Dermatology Life Quality Index (DLQI) change
Description
Change from baseline in plaque psoriasis as assessed by DLQI (dermatology life quality index ) response
Time Frame
24 weeks
Title
adverse events(AEs)
Description
Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults of both sexes, at least 18 years of age
have stable plaque psoriasis for at least 6 months, psoriasis involving at least 10 percent of the body surface area, had a minimal PASI of 10 at screening
had previously received phototherapy or systemic psoriasis therapy at least once or candidates for such therapy in the opinion of the investigator
Exclusion Criteria:
Patients with guttate, erythrodermic, or pustular psoriasis at the time of screening
recent infection or opportunistic infections, active tuberculosis, hepatitis B and so on
liver and kidney dysfunction
those with other serious, progressive, uncontrolled disorders of vital organs and systems (including cardiovascular, liver, lung and kidney), other autoimmune diseases, cancer, HIV infection, which are not suitable for participation in the study of the disease
history of significant methotrexate toxicity or total cumulative methotrexate exposure > 1000 mg (unless grade ‡ IIIb liver injury has not occurred)
use of ultraviolet (UV) B therapy, topical ciclosporin or calcineurin inhibitors, class III through VII topical corticosteroids (permitted on the scalp, axillae, and ⁄or groin), or topical vitamin A or D analogues within 14 days of screening
and psoralen or UVA therapy, systemic psoriasis therapy (including methotrexate), oral retinoids, class I or II topical corticosteroids, dithranol, cyclophosphamide, sulfasalazine, or intravenous or oral calcineurin inhibitors within 28 days of screening
Patients were excluded if they had received a tumor necrosis factor (TNF) blocking agent or other biologics within 3 months or interleukin (IL)-12 or IL-23 inhibitors within 6 months of study initiation
Facility Information:
Facility Name
the 2Nd Affiliated Hospital,Zhejiang University,
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Learn more about this trial
Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate
We'll reach out to this number within 24 hrs