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Completed

NCT Number: NCT02313922

Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate

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%)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the 2Nd Affiliated Hospital,Zhejiang University,

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept combined with methotrexate or etanercept combined with placebo

Drug

Primary outcomes

  1. psoriasis area and severity index 75(PASI75)

    Time frame: 24 weeks

    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 outcomes

  1. psoriasis area and severity index 50(pasi 50)

    Time frame: 24 weeks

    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%)

  2. psoriasis area and severity index 90(pasi 90)

    Time frame: 24 weeks

    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%)

  3. Dermatology Life Quality Index (DLQI) change

    Time frame: 24 weeks

    Change from baseline in plaque psoriasis as assessed by DLQI (dermatology life quality index ) response

  4. adverse events(AEs)

    Time frame: 24 weeks

    Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

  • Shanghai CP Guojian Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 10, 2014
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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