therapeutic drug monitoring: towards tailored dosing of adalimumab in rheumatoid arthritis

therapeutic drug monitoring: towards tailored dosing of adalimumab in rheumatoid arthritis - therapeutic drug monitoring of adalimumab in rheumatoid arthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41716

Enrollment

112

Registered

2012-10-04

Start date

2012-11-12

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoide arthritis

Interventions

Patients with high adalimumab concentrations will be randomly assigned for continuation of adalimumab every other week or prolongation of the dosage interval to once every 3 weeks. Patients assigned

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: RA according to the ACR 1987 criteria Adalimumab treatment for at least 28 weeks Trough adalimumab level > 12 mg/L Treating rheumatologist is convinced of the benefit of adalimumab continuation Written informed consent

Exclusion criteria

Exclusion criteria: Scheduled surgery in the next 6 months or other pre planned reasons for treatment discontinuation.

Design outcomes

Primary

Measure	Time frame
Similar DAS28 in patients with high serum adalimumab concentrations who are randomly assigned to continuation of the regular dose or to dose interval prolongation. A clinically relevant difference in disease activity is defined as a DAS28 > 0.6.	—

Secondary

Measure	Time frame
Cost-effectiveness of therapeutic drug monitoring in rheumatoid arthritis patients responding to adalimumab.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)