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Discontinuation of Disease-modifying Anti-rheumatic Drugs (DMARDs) in Rheumatoid Arthritis Patients Also Using TNF Inhibitors
Sponsor: Sint Maartenskliniek
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.
Official title: DISCO: DIScontinuation of COncomitant Disease Modifying Anti-rheumatic Drugs (DMARDs) in Rheumatoid Arthritis Patients Also Using TNF Inhibitors - a Randomized Long-term Non-inferiority Strategy Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2026-07-14
Completion Date
2029-05-01
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (4)
Sint Maartenskliniek
Nijmegen, Gelderland, Netherlands
Elisabeth-TweeSteden Ziekenhuis Tilburg
Tilburg, North Brabant, Netherlands
Reade Amsterdam
Amsterdam, North Holland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands