Use of Tocilizumab Drug Levels to Optimize Treatment in RA

Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, multicenter, non-inferiority trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20556

Enrollment

Registered

2019-07-17

Start date

2019-08-01

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

Interventions

Patients with tocilizumab trough concentrations above 15 mg/L will be randomly assigned to dose reduction by increasing their dosing interval from once every week to once every two weeks, or to contin

Eligibility

Inclusion criteria

Inclusion criteria: - Rheumatoid arthritis according to the American College of Rheumatology (ACR) 1987 or 2010 criteria; - Current use of subcutaneous tocilizumab 162 mg weekly, for at leas the previous 6 months; - The treating rheumatologist is convinced of the benefit of tocilizumab continuation; - Written informed consent.

Exclusion criteria

Exclusion criteria: - A scheduled surgery in the next 52 weeks or other pre-planned reasons for treatment discontinuation; - Changes in the treatment with glucocorticoids or DMARDs such as methotrexate in the past three months.

Design outcomes

Primary

Measure	Time frame
The main objective is to investigate the difference in mean time weighted Disease Activity Score in 28 joints, including erythrocyte sedimentation rate (DAS28-ESR) after 28 weeks in RA patients with serum concentrations higher than 15 mg/L who are randomly assigned to continuation of the standard dose or to increase dosing interval to every two weeks.	—

Secondary

Measure	Time frame
The secondary objectives are to investigate the difference in mean time weighted DAS28-ESR after 52 weeks between patients undergoing concentration-guided dose reduction or standard dosing; to investigate the difference in Clinical Disease Activity Index (CDAI), Simple Disease Activity Index (SDAI), and Health Assessment Questionnaire (HAQ) after both 28 and 52 weeks between the two treatment groups; to study the direct medical costs of applying therapeutic drug monitoring (TDM); to study the difference in number of flares at 28 and 52 weeks between the two treatment arms; to investigate the difference in number and severity of adverse events at 28 and 52 weeks in both treatment arms; to study the difference in drug level in the intervention group between week 0 and 52; and to study the perspective of patients towards concentration-guided dosing.	—

Measure

Time frame

The secondary objectives are to investigate the difference in mean time weighted DAS28-ESR after 52 weeks between patients undergoing concentration-guided dose reduction or standard dosing; to investigate the difference in Clinical Disease Activity Index (CDAI), Simple Disease Activity Index (SDAI), and Health Assessment Questionnaire (HAQ) after both 28 and 52 weeks between the two treatment groups; to study the direct medical costs of applying therapeutic drug monitoring (TDM); to study the difference in number of flares at 28 and 52 weeks between the two treatment arms; to investigate the difference in number and severity of adverse events at 28 and 52 weeks in both treatment arms; to study the difference in drug level in the intervention group between week 0 and 52; and to study the perspective of patients towards concentration-guided dosing.

—

Contacts

Public ContactFemke Hooijberg

Reade, Jan van Breemen Research Institute

f.hooijberg@reade.nl0202421633

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)