NCT02313922

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%)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
466

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

3.8 years

First QC Date

December 8, 2014

Last Update Submit

August 16, 2018

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • psoriasis area and severity index 50(pasi 50)

    24 weeks

  • psoriasis area and severity index 90(pasi 90)

    24 weeks

  • Dermatology Life Quality Index (DLQI) change

    24 weeks

  • adverse events(AEs)

    24 weeks

Study Arms (2)

etanercept combined with methotrexate

EXPERIMENTAL

patients treated with etanercept combined with methotrexate

Drug: etanercept combined with methotrexate or etanercept combined with placebo

etanercept as monotherapy

EXPERIMENTAL

patients treated with etanercept combined with placebo

Drug: etanercept combined with methotrexate or etanercept combined with placebo

Interventions

etanercept combined with methotrexate or etanercept combined with placeboDRUG
etanercept as monotherapyetanercept combined with methotrexate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the 2Nd Affiliated Hospital,Zhejiang University,

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of dermatology

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 10, 2014

Study Start

November 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

CN(1)