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Tight Control Dose Reductions of Biologics in Psoriasis Patients With Low Disease Activity

NCT02602925 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-04-01

No results posted yet for this study

Summary

Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics.

Objective To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease.

Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with cost-effectiveness analysis.

Study population: Patients with disease remission using normal dose of biologics.

Intervention: 120 patients will be randomized into two groups: (1) dose reduction and (2) normal dose.

Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary outcomes are: health-related quality of life (HRQoL), number and time to disease flares, costs, health status, anti-drug antibody formation and serious adverse events

Conditions

Interventions

OTHER

Dose decrease

Treatment strategy change: dose decrease based on PASI and DLQI

OTHER

Usual care

Usual care

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • E de Jong, MD · Dept. of Dermatology, Radboudumc, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-07-20
Completion
2018-07-20

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02602925 on ClinicalTrials.gov