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

Inclusion Criteria4

  • 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 Criteria3

  • 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.

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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