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Could fewer pills mean same relief for rheumatoid arthritis?

NCT ID NCT07802678

Disease control Sponsor: Sint Maartenskliniek Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether people with rheumatoid arthritis who have stable disease can stop taking methotrexate or leflunomide while continuing their TNF inhibitor, restarting the drug if needed. Researchers compare this approach to staying on the combination therapy. They track disease activity over 24 months, along with flares, safety, and quality of life. The goal is to see if reducing medication is a viable option without losing control of the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A strategy to discontinue methotrexate or leflunomide while continuing TNF inhibitor therapy, with restart if needed
What this could lead to
If successful, this could allow many rheumatoid arthritis patients to take fewer medications without losing disease control, reducing side effects and costs.
What could go wrong
The trial is a strategy test, not a new drug, and results may show that stopping these drugs leads to more flares or worse disease activity over time. Individual responses vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 202 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis (RA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Elisabeth-TweeSteden Ziekenhuis Tilburg

    NOT_YET_RECRUITING

    Tilburg, North Brabant, 5022 GC, Netherlands

  • Erasmus MC

    NOT_YET_RECRUITING

    Rotterdam, South Holland, 3015GJ, Netherlands

  • Reade Amsterdam

    NOT_YET_RECRUITING

    Amsterdam, North Holland, 1056 AA, Netherlands

  • Sint Maartenskliniek

    RECRUITING

    Nijmegen, Gelderland, 6574NA, Netherlands

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