Prediction aided tapering in reumatoid arthritis patients treated with biologicals
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NL-OMON19954
- Lead Sponsor
- ZonMW
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
• 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
• 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 The mean number of flares per patient over 18 months.
- Secondary Outcome Measures
Name Time Method Mean dose reduction of biological (expressed as percentage of full-dose)<br>DAS28-CRP over time <br>Number of patients with any major flare (flare duration >12 weeks)<br>Functional disability (HAQ) over time<br>Quality of Life (EQ5D5L) over time<br>Provider assessed general disease activity (GDA) on a VAS over time<br>Patient assessed pain on a VAS over time<br>Flare severity score: OMERACT RA Flare questionnaire over time<br>Patient Acceptable Symptom State (PASS) over time<br>Likert transition question over time<br>(Serious) Adverse Events