Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate

NCT ID: NCT02313922

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 466 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-08-31

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%)

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

etanercept combined with methotrexate

patients treated with etanercept combined with methotrexate

Group Type: EXPERIMENTAL

etanercept combined with methotrexate or etanercept combined with placebo

Intervention Type: DRUG

etanercept as monotherapy

patients treated with etanercept combined with placebo

Group Type: EXPERIMENTAL

etanercept combined with methotrexate or etanercept combined with placebo

Intervention Type: DRUG

Interventions

etanercept combined with methotrexate or etanercept combined with placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai CP Guojian Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Min Zheng

director of dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the 2Nd Affiliated Hospital,Zhejiang University,

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

C301-PS

Identifier Type: -

Identifier Source: org_study_id