Prediction aided tapering in reumatoid arthritis patients treated with biologicals

Recruiting

• Conditions: rheumatism; rheumatoid arthritis; 10003816; 10023213

• Registration Number: NL-OMON56102
• Lead Sponsor: niversitair Medisch Centrum Utrecht

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: Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

• A clinical diagnosis of rheumatoid arthritis as assessed by the treating
rheumatologist.
It will be registered if patients meet ACR 1987 or EULAR/ACR 2010 criteria. If
these criteria are not met, the separate components of the criteria will be
registered.
• Treatment of their RA with one of the following bDMARDs that are registered
for RA in >=66% of the standard dose (i.e. maximally one dose reduction step
previously taken): adalimumab, certolizumab, golimumab, infliximab, etanercept,
sarilumab, tocilizumab or abatacept).
• Patient is eligible to taper bDMARD according to treating physician (i.e. no
other indication for bDMARD such as psoriasis or IBD, i.e. no recent relevant
radiographic progression).
• Stable low disease activity with current bDMARD for >= 6 months according to
treating physician
• Current DAS28-CRP <= 2.9 (low disease activity)
or
Current stable low disease activity according to treating physician and patient
with a maximum DAS28-CRP <=3.5 (i.e. 2.9 + measurement error in DAS28
(~0.6)(33)).
• Patient is willing to taper (and if possible, stop) his/her bDMARD as well as
to continue his/her current bDMARD dose.
• At least 18 years of age

Exclusion Criteria

• Recent earlier (<6 months) tapering attempt(s) with the same bDMARD that
failed according to treating physician
• Inability to comply with protocol, e.g. no possibility to measure outcome
over 18 months, e.g. insufficient knowledge of the Dutch language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: the number of flares per patient over 18 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Main secondary endpoint: dose reduction (expressed as percentage of full-dose)<br /><br>over 18 months.</p><br>