se of Tocilizumab Drug Levels to Optimize Treatment in RA

Recruiting

Conditions: Rheumatoid Arthritis

Registration Number: NL-OMON20556

Lead Sponsor: Reade Rheumatology Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 98

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.