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

Who is this study for? Patients with rheumatoid arthritis
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Reade Rheumatology Research Institute
RECRUITING
Amsterdam
Contact Information
Primary
Sadaf Atiqi, MD
s.atiqi@reade.nl
0031-202421641
Backup
Femke Hooijberg
f.hooijberg@reade.nl
0031202421633
Time Frame
Start Date: 2020-03-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 267
Treatments
Experimental: Concentration guided dose reducion
Dose reduction of adalimumab will be based on adalimumab through concentration after 16 weeks of treatment with adalimumab.
Active_comparator: Disease activity quided dose reduction
Dose reduction of adalimumab will be based on disease activity after 28 weeks of treatment with adalimumab
Sponsors
Leads: Reade Rheumatology Research Institute
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Sint Maartenskliniek

This content was sourced from clinicaltrials.gov