TOCILIZUMAB for Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Rheumatoid arthritis according to the ACR 1987 or 2010 criteria\n- Current use of subcutaneous tocilizumab 162 mg weekly , for at least the last 6 months\n- The treating rheumatologist is convinced of the benefit of tocilizumab continuation\n- No changes in the treatment with glucocorticoids and DMARDs such as methotrexate in the past three months\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- A scheduled surgery in the next 52 weeks or other pre-planned reasons for treatment discontinuation"}

Primary endpoints

• {"endpoint_text":"- The primary objective of this study is to investigate the difference in mean time weighted DAS28 after 28 weeks between concentration-guided dose reduction and standard dosing. This analysis will be based on the non-inferiority principle, since we expect no worse outcome for patients in whom the dosing interval will be adjusted compared to patients who continue on the regular tocilizumab dose. As explained in the sample size calculation, the mean time weighted DAS28 is expected to be 2.8, with a","definition_or_measurement_approach":"Mean time-weighted DAS28-ESR after 28 weeks; non-inferiority analysis comparing concentration-guided dose reduction versus standard dosing; expected mean time-weighted DAS28 approximately 2.8 (as used in sample size calculation)."}

Secondary endpoints

• {"endpoint_text":"- We will look at the difference in mean time weighted DAS28 after 52 weeks between the two treatment groups.","definition_or_measurement_approach":"Mean time-weighted DAS28-ESR after 52 weeks comparing groups."}
• {"endpoint_text":"- The difference in CDAI, SDAI, and HAQ score after 28 weeks and 52 weeks between the two treatment groups","definition_or_measurement_approach":"Comparative changes in CDAI, SDAI and HAQ scores at 28 and 52 weeks between arms."}
• {"endpoint_text":"- The direct medical costs of TDM compared to the standard treatment regimen","definition_or_measurement_approach":"Health economic comparison of direct medical costs between therapeutic drug monitoring (TDM) guided dosing and standard regimen."}
• {"endpoint_text":"- The difference in number of flares between the two treatment arms at 28 and 52 weeks","definition_or_measurement_approach":"Count and compare number of disease flares at 28 and 52 weeks between arms."}
• {"endpoint_text":"- The number and severity of adverse events in both treatment arms","definition_or_measurement_approach":"Safety assessment: incidence and severity grading of adverse events in each arm."}
• {"endpoint_text":"- The difference in drug levels in the intervention group between week 0 and 52","definition_or_measurement_approach":"Measurement of tocilizumab serum drug levels baseline and week 52 within intervention group; comparison of change."}
• {"endpoint_text":"- The change in drug levels from baseline after 52 weeks of intervention","definition_or_measurement_approach":"Change in serum tocilizumab concentration from baseline to week 52."}
• {"endpoint_text":"- The relationship between dose, drug concentration, and clinical disease activity","definition_or_measurement_approach":"Pharmacokinetic/pharmacodynamic analysis correlating dose and serum concentrations with clinical activity measures."}
• {"endpoint_text":"- The therapeutic range of tocilizumab","definition_or_measurement_approach":"Derivation of a therapeutic concentration range based on clinical outcomes and drug levels."}
• {"endpoint_text":"- The development of a pharmacokinetic model resulting in a dashboard system","definition_or_measurement_approach":"Development of PK model and implementation as a dashboard tool (modeling and tool development endpoints)."}
• {"endpoint_text":"- The perspective of the patients about optimizing their dose with therapeutic drug monitoring","definition_or_measurement_approach":"Patient-reported perspective assessments regarding dose optimization with TDM (qualitative/quantitative patient perspective measures)."}

Netherlands

Earliest CTIS Part Ii Submission Date

15-01-2025

Latest Decision Or Authorization Date

16-01-2025

Processing Time Days

1

Number Of Sites

6

Number Of Participants

98

Primary sponsor

Full Name

Reade revalidatie & reumatologie centrum te Amsterdam

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands