Therapeutic drug monitoring: Toward tailored dosing of adalimumab in rheumatoid arthritis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29559

Enrollment

102

Registered

2012-07-05

Start date

2012-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

rheumatoid arthritis adalimumab therapeutic drug monitoring

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. RA according to the ACR 1987 criteria; 2. Adalimumab treatment for at least 28 weeks; 3. Treating rheumatologist is convinced of the benefit of adalimumab continuation; 4. Written informed consent. 5. Trough adalimumab level > 8.0 mg/L

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 deltaDAS28 in patients with high serum adalimumab concentrations who are randomly assigned to continuation of the regular dose or to dose interval prolongation.	—

Secondary

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

Contacts

Public ContactG.J. Wolbink

Dr. Jan van Breemenstraat 2, 1065 AB Amsterdam

g.wolbink@reade.nl020-5896 589

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)