BridgeMD
Discontinuation of disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis patients also using TNF inhibitors
EU CTIS ID: 2026-525316-33-00
What this study is testing
The primary objective is to investigate whether a strategy to attempt discontinuation of MTX or LEF (and restart when necessary) in RA patients treated with an optimal dose TNFi is non-inferior to a continuation of combination therapy strategy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 with MTX or LEF at a stable dose for at least 3 months and a TNFi at an optimal dose (optimal dose is defined as the authorized dose or lower and being maximally tapered, because of prior disease flare or patient preference)
- Ability to comply with all study procedures, visits and follow-up assessments
- Written informed consent provided prior to any study-related procedure
You likely can't join if
- 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
See the full eligibility 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 with MTX or LEF at a stable dose for at least 3 months and a TNFi at an optimal dose (optimal dose is defined as the authorized dose or lower and being maximally tapered, because of prior disease flare or patient preference)
- Ability to comply with all study procedures, visits and follow-up assessments
- Written informed consent provided prior to any study-related procedure
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.