Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reade Rheumatology Research Institute
• Collaborators: Sint Maartenskliniek; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Rheumatoid arthritis patient, according to ACR 1987 or ACR/EULAR 2010

• Treated for at least 28 weeks with adalimumab

• Adalimumab trough concentration >5mg/L

• 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