Better After Choosing: Filgotinib versus TNF inhibitor options for rheumatoid arthritis

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

The trial enrolls adults with active RA who have had an inadequate response to at least one conventional synthetic DMARD and who have not previously received biological DMARDs. Participants are allocated either to a patient-choice arm (about 50 patients may freely choose filgotinib or a TNF inhibitor) or to a randomized arm where they are assigned to one of those treatments. Investigators will compare treatment satisfaction, adherence, disease activity (DAS28), physical function (HAQ), activity (SQUASH) and work productivity (WPAI) between the arms using validated questionnaires and standard clinical assessments. Follow-up visits and objective disease measures will be used to track outcomes over the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Demographic and general characteristics:

* Adult male or female patients, at least 18 years of age.
* Able and willing to give written informed consent.
* Have sufficient knowledge of the Dutch language to be able to comply with the requirements of the study protocol.

Inclusion criteria:

* Diagnosis of adult-onset RA as defined by the 2010 ACR/ EULAR Rheumatoid arthritis classification criteria;
* Diagnosis of RA for ≥ three months;
* Are being treated ≥ three months with ≥ 1 csDMARD therapy;
* Have had an inadequate response or intolerance to at least 1 csDMARD;
* Have moderately to severely active RA to the discretion of the rheumatologist or defined as a DAS28 ≥ 3.2 at screening and baseline visits;
* Subjects must have been on a stable dose of csDMARD therapy (restricted to methotrexate, chloroquine, hydroxychloroquine, sulfasalazine, or leflunomide) for ≥ 4 weeks prior to the baseline visit.

Exclusion Criteria:

* Previous treatment with any biological DMARD or targeted synthetic DMARD/JAKi;
* Inflammatory rheumatic disease other than RA, except for secondary Sjögren's syndrome.
* Having a contraindication for either TNFi or filgotinib;
* Latent or active tuberculosis;
* Active or recurrent infections;
* History of any malignancy within 5 years except for successfully treated NMSC or localized carcinoma in situ of the cervix;
* ≥ 3x upper limit of normal ALT, AST;
* eGFR ≤ 30 ml/min;
* planned or actual pregnancy or planning to father a child.

Where it's running

• Medical Center Leeuwarden MCL
  Leeuwarden, Netherlands Recruiting

Study contacts

• Principal investigator: Reinhard Bos, MD PhD — Rheumatology Research Center Northern Netherlands
• Study coordinator: Reinhard Bos, MD PhD
• Email: r.bos@mcl.nl
• Phone: 0031(0)582866104

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.