Discontinuing MTX or LEF in RA Patients on TNF Inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with rheumatoid arthritis who are well controlled on a TNF inhibitor plus MTX or LEF will be randomized to try stopping MTX or LEF (with restart if needed) or to continue the current combination. The study follows participants for 24 months with visits at baseline, 3, 6, 12, 18, and 24 months, plus visits for disease flares and remote check-ins; imaging may be collected. The main outcome is average disease activity over 24 months to see if stopping MTX/LEF is non-inferior to continuing combination therapy. Safety, patient experiences, medication use, and healthcare costs will also be explored.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sint Maartenskliniek
  Nijmegen, Gelderland, Netherlands Recruiting
• Elisabeth-TweeSteden Ziekenhuis Tilburg
  Tilburg, North Brabant, Netherlands Not yet recruiting
• Reade Amsterdam
  Amsterdam, North Holland, Netherlands Not yet recruiting
• Erasmus MC
  Rotterdam, South Holland, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Alfons den Broeder, Dr.
• Email: a.denbroeder@maartenskliniek.nl
• Phone: ++ 31 24 365 9279

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.