NCT07802678RecruitingPhase 4
Discontinuation of Disease-modifying Anti-rheumatic Drugs (DMARDs) in Rheumatoid Arthritis Patients Also Using TNF Inhibitors
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- First submitted
- 4 Aug 2026
- Start date
- 14 Jul 2026
- Primary completion date
- 1 May 2029
- Lead sponsor
- Sint Maartenskliniek
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07802678
- EU CT number
- 2026-525316-33-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 202
- From 14 Jul 2026 to the primary completion date, 1 May 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Reade revalidatie & reumatologie centrum te Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Elisabeth-Tweesteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
| Sint Maartenskliniek Stichting Coordinator of this site? Confirm its status | Ubbergen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.