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Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate

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ClinicalTrials.gov Identifier: NCT02313922
Recruitment Status : Completed
First Posted : December 10, 2014
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
Shanghai CP Guojian Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Min Zheng, Zhejiang University

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%)

Condition or disease Intervention/treatment Phase
Psoriasis Drug: etanercept combined with methotrexate or etanercept combined with placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate: a Phase IV, Multicenter, Randomized, Double-blind, Controlled Trial
Study Start Date : November 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: etanercept combined with methotrexate
patients treated with etanercept combined with methotrexate
Drug: etanercept combined with methotrexate or etanercept combined with placebo
Experimental: etanercept as monotherapy
patients treated with etanercept combined with placebo
Drug: etanercept combined with methotrexate or etanercept combined with placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313922


Locations
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China, Zhejiang
the 2Nd Affiliated Hospital,Zhejiang University,
Hangzhou, Zhejiang, China, 310009
Sponsors and Collaborators
Zhejiang University
Shanghai CP Guojian Pharmaceutical Co., Ltd.

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Responsible Party: Min Zheng, director of dermatology, Zhejiang University
ClinicalTrials.gov Identifier: NCT02313922     History of Changes
Other Study ID Numbers: C301-PS
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Gastrointestinal Agents