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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Rheumatoid arthritis patient, according to ACR 1987 or ACR/EULAR 2010 criteria; - Starting adalimumab as the first biological therapy - Who has agreed to participate (written willing to sign a consent form); - Age 18 years or older. Who Should NOT Join This Trial: - Scheduled surgery during the follow-up of the study or other pre-planned reasons for treatment discontinuation; - Life expectancy shorter than follow-up period of the study; - Other disease that might flare if adalimumab is tapered like psoriasis, inflammatory bowel disease. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Rheumatoid arthritis patient, according to ACR 1987 or ACR/EULAR 2010 criteria; * Starting adalimumab as the first biological therapy * Who has agreed to participate (written informed consent); * Age 18 years or older. Exclusion Criteria: * Scheduled surgery during the follow-up of the study or other pre-planned reasons for treatment discontinuation; * Life expectancy shorter than follow-up period of the study; * Other disease that might flare if adalimumab is tapered like psoriasis, inflammatory bowel disease.

Treatments Being Tested

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

Locations (1)

Reade Rheumatology Research Institute
Amsterdam, North Holland, Netherlands