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Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity

NCT04222920 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-11-18

No results posted yet for this study

Summary

Several prior studies have shown that dose reduction or discontinuation of tumor necrosis factor (TNF)-inhibitors, like adalimumab, is possible in substantial number of patients with a rheumatic disease without an increase in disease activity. Prior studies showed that patients with concentrations higher than 5 mg/L are overexposed to adalimumab and can safely reduce the dose. In the first phase of treatment, an adalimumab concentration of 5mg/L is needed to achieve adequate clinical response. However to control disease activity after 28 weeks, lower concentration than 5 mg/L are probably sufficient. Recent published data suggest that concentrations of 0.1-0.5 mg/L are enough to control TNF blockade in this state. Yet, a study which investigates the lowest effective drug serum concentration is missing so far. The hypothesis is that serum adalimumab concentration of 2 mg/L is sufficient to control disease activity.

Conditions

Interventions

OTHER

Dose reduction to 2mg/L

Adalimumab dose reduction aiming drug concentration of 2mg/L

OTHER

Dose reduction to 5mg/L

Adalimumab dose reduction aiming drug concentration of 5mg/L

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, MD, 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
2023-09-11
Completion
2023-09-11

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 NCT04222920 on ClinicalTrials.gov