Determination of tocilizumab trough levels during dose tapering in patients with rheumatoid arthritis (OPTIRA study)

Phase 4

• Conditions: gewrichtsaandoeningen; chronic inflammatory joint disease; rheumatic disorder; Rheumatoid arthritis; 10003816

• Registration Number: NL-OMON53280
• Lead Sponsor: Franciscus Gasthuis & Vlietland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

- >=18 years of age - Diagnosed with rheumatoid arthritis and treated for it in
Franciscus Gasthuis and Vlietland - Treated with intravenous or subcutaneous
tocilizumab - Low disease activity for at least the last 6 months while using
tocilizumab with a current DAS28-ESR <=3.2. - Sufficient understanding of the
Dutch language.

Exclusion Criteria

none

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of this study are:<br /><br>- the percentage of patients in whom tocilizumab is successfully tapered after<br /><br>12 months (successful = lower dose than at baseline with a concurrent DAS28-ESR<br /><br><=3.2).<br /><br>- the serum concentration range of tocilizumab above which low disease activity<br /><br>is maintained during tapering of tocilizumab. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints of this study are:<br /><br>- the mean or median dose reduction or interval extension of tocilizumab<br /><br>between baseline and 12 months (in mg and percentages).<br /><br>- the mean or median change in disease activity scores between baseline and 12<br /><br>months.</p><br>