RecruitingPhase 4NCT04194827

Adalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug Monitoring

Adalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug Monitoring (ADDORA): Multi-centre Open Label Randomised Controlled Trail


Sponsor

Reade Rheumatology Research Institute

Enrollment

267 participants

Start Date

Mar 1, 2020

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether the dose of adalimumab (a biologic injection used for rheumatoid arthritis) can be safely reduced or stopped over time in patients who are doing well, using drug level measurements to guide the decision. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis - You are starting adalimumab as your first biologic medication - You are 18 or older - You agree to participate and provide written consent **You may NOT be eligible if...** - You have planned surgery during the study period - You have a life expectancy shorter than the study follow-up period - You have another condition (such as psoriasis or inflammatory bowel disease) that could flare if the adalimumab dose is reduced Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTAdalimumab serum trough concentration

Dose reduction based on adalimumab serum trough concentration

DIAGNOSTIC_TESTDisease activity

Dose reduction based on adalimumab diseas activity

DRUGAdalimumab

Adalimumab


Locations(1)

Reade Rheumatology Research Institute

Amsterdam, North Holland, Netherlands

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NCT04194827


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