Adalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug Monitoring

Sponsor
Reade Rheumatology Research Institute
Study ID
NCT04194827
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Mar 1, 2020
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
267 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Medical costs [ Time Frame: 52 weeks ]

Central Contacts

Related Studies