Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity
Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
Summary
Several prior studies have shown that dose reduction or discontinuation of tumor necrosis
factor (TNF)-inhibitors, like adalimumab, is possible in substantial number of patients with
a rheumatic disease without an increase in disease activity. Prior studies showed that
patients with concentrations higher than 5 mg/L are overexposed to adalimumab and can safely
reduce the dose. In the first phase of treatment, an adalimumab concentration of 5mg/L is
needed to achieve adequate clinical response. However to control disease activity after 28
weeks, lower concentration than 5 mg/L are probably sufficient. Recent published data suggest
that concentrations of 0.1-0.5 mg/L are enough to control TNF blockade in this state. Yet, a
study which investigates the lowest effective drug serum concentration is missing so far. The
hypothesis is that serum adalimumab concentration of 2 mg/L is sufficient to control disease
activity.
Phase:
Phase 4
Details
Lead Sponsor:
Reade Rheumatology Research Institute
Collaborators:
Sint Maartenskliniek ZonMw: The Netherlands Organisation for Health Research and Development