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Adalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug Monitoring

NCT04194827 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2024-04-18

No results posted yet for this study

Summary

Several prior studies have shown that dose reduction of Tumor Necrosis Factor (TNF)-inhibitors like adalimumab is possible in substantial number of rheumatic disease patients without an increase in disease activity. Biologic therapy is expensive, and is associated with patient burden as dose dependant risk for serious infections . A dose reduction will decrease the risk of side effects and result in substantial cost savings. Currently, most clinicians use Disease Activity Score in 28 joints (DAS28) and the Clinical Disease Activity Index (CDAI) to monitor dose tapering strategies. Although this approach is cost-effective, it might be improved by information on the extent of drug levels, as several studies have shown that adalimumab drug levels are associated with clinical outcome. Therefore, a study comparing dose reduction strategy using drug concentration with dose reduction strategy using disease activity is timely

Conditions

Interventions

DIAGNOSTIC_TEST

Adalimumab serum trough concentration

Dose reduction based on adalimumab serum trough concentration

DIAGNOSTIC_TEST

Disease activity

Dose reduction based on adalimumab diseas activity

DRUG

Adalimumab

Adalimumab

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Sint Maartenskliniek

    collaborator OTHER

  • Reade Rheumatology Research Institute

    lead OTHER

Principal Investigators

  • Gertjan Wolbink, PhD · Reade Rheumatology Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
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 NCT04194827 on ClinicalTrials.gov