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RECRUITING
NCT07802678
PHASE4

Discontinuation of Disease-modifying Anti-rheumatic Drugs (DMARDs) in Rheumatoid Arthritis Patients Also Using TNF Inhibitors

Sponsor: Sint Maartenskliniek

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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