Strategy to attempt discontinuation of MTX or LEF (and restart when necessary)Continuation of MTX or LEF
Strategy to attempt discontinuation of MTX or LEF (and restart when necessary): Participants will discontinue their csDMARD (MTX or LEF) immediately following randomization and continue TNFi monotherapy at their current stable dose.
Continuation of MTX or LEF: Participants will aim to continue combination therapy with csDMARD (MTX or LEF) and TNFi at their current stable doses.
Study summary
The goal is to investigate whether a strategy of attempting to discontinue of MTX or LEF (and restart when necessary) in RA patients treated with an optimal dose (allowed dose or lower, tapered to the maximum, or according to patient preference) TNFi is not worser to a continuation of combination therapy. The study will also examine the disease-related effects of treatment that attempts to discontinue MTX or LEF, how patients experience it, its safety, and its impact on medication usage and healthcare costs.
The main outcome is the difference between treatments in average disease activity over 24 months. The study will compare whether disease activity remains similar between patients who attempt to discontinue MTX or LEF and those who continue combination therapy.
Patients will be followed for 24 months with scheduled hospital visits at baseline, after 3, 6, 12, 18, and 24 months, remote visits, and additional visits for disease flares. X-rays of the hands and feet will be taken at baseline and after 24 months. During some visits, additional blood samples will be taken to measure inflammation markers and medication levels.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years.
* Diagnosis of RA, according to the 2010 ACR/EULAR and/or 1987 RA classification criteria or clinical diagnosis by a rheumatologist.
* Stable disease activity for ≥ 6 months, defined as DAS28-CRP ≤ 2.9 or DAS28-CRP ≤ 3.5 combined with clinical judgment of LDA.
* Current combination therapy consisting of TNFi and either MTX or LEF.
* TNFi administration at a stable dose (at an optimal dose, defined as the authorized dose or lower and being maximally tapered, because of prior disease flare or patient preference) for ≥6 months prior to screening, during which LDA is maintained for ≥6 months.
* MTX or LEF administration at a stable dose for ≥3 months prior to screening.
* Ability to comply with all study procedures, visits and follow-up assessments.
* Written informed consent provided prior to any study-related procedure.
Exclusion Criteria:
* A previous attempt within the last 12 months prior to screening to taper or discontinue MTX or LEF that required reintroduction or dose increase of the csDMARD due to a disease flare.
* Current MTX or LEF treatment for other indications than RA.
* Current treatment with prednisolone (equivalent) of \> 5 mg per day.
* Current severe comorbidity or serious life-shortening condition that could interfere with adherence to the study protocol or completion of the 24-month follow-up period.
* Women that are pregnant, breast feeding or considering pregnancy during the study period (MTX and LEF are contraindicated in pregnancy and breastfeeding).
* Inability to comply with the study procedures, visits, or follow-up assessments.
* Inability or unwillingness to provide informed consent.
Primary outcome measure(s)
The between-group difference in mean time-weighted DAS28-CRP during 24 months of follow-up. — At 24 months of follow-up. The between-group difference in mean time-weighted DAS28-CRP during 24 months of follow-up. A mean time-weighted DAS28-CRP is chosen to balance the limitations of assessing disease activity at a single timepoint with solely considering the occurrence of flare. The time-weighted DAS28-CRP consists of a weighted average of a patient's DAS28-CRP scores, calculated using the trapezoid method and weighed by the time interval between measurements.
Trial sites (4)
Facility
City
Region
Status
Sint Maartenskliniek
Nijmegen
Gelderland
Recruiting
Elisabeth-TweeSteden Ziekenhuis Tilburg
Tilburg
North Brabant
Not Yet Recruiting
Reade Amsterdam
Amsterdam
North Holland
Not Yet Recruiting
Erasmus MC
Rotterdam
South Holland
Not Yet Recruiting
More Sint Maartenskliniek trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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