Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate

Psoriasis Clinical Trial

Official title:

Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate: a Phase IV, Multicenter, Randomized, Double-blind, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313922
• Other study ID #: C301-PS
• Status: Completed
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 466
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• etanercept combined with methotrexate or etanercept combined with placebo

Locations

Country	Name	City	State
China	the 2Nd Affiliated Hospital,Zhejiang University,	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Shanghai CP Guojian Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%)	24 weeks
Secondary	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%)	24 weeks
Secondary	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%)	24 weeks
Secondary	Dermatology Life Quality Index (DLQI) change	Change from baseline in plaque psoriasis as assessed by DLQI (dermatology life quality index ) response	24 weeks
Secondary	adverse events(AEs)	Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs	24 weeks