Stopping methotrexate or leflunomide in rheumatoid arthritis patients also taking TNF inhibitors
Compares trying to stop methotrexate or leflunomide with continuing it, in rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Discontinuation of Disease-modifying Anti-rheumatic Drugs (DMARDs) in Rheumatoid Arthritis Patients Also Using TNF Inhibitors
Key facts
- Where
- Amsterdam, Rotterdam, Tilburg, and Ubbergen, NetherlandsSee the 4 sites
- Phase
- Phase 4
Where in Netherlands
- Reade revalidatie & reumatologie centrum te AmsterdamAmsterdam, NetherlandsTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
- Elisabeth-Tweesteden ZiekenhuisTilburg, NetherlandsTaking people
- Sint Maartenskliniek StichtingUbbergen, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sint Maartenskliniek
- Trial code
- NCT07802678EU 2026-525316-33-00
- Record updated
- 3 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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 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; Current MTX or LEF treatment for other indications than RA; 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.