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

Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in Patients With Active Rheumatoid Arthritis (BACH)

This trial will test whether letting adults with active rheumatoid arthritis choose between the oral JAK inhibitor filgotinib or a TNF-blocking biologic leads to higher treatment satisfaction compared with being randomly assigned to one of those treatments.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 101 Years
• Sex: All
• Sponsor: Rheumatology Research Center Northern Netherlands (Academic / other)
• Drugs / interventions: filgotinib, methotrexate, adalimumab
• Locations: 1 site (Leeuwarden)
• Trial ID: NCT04985435 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with adult-onset RA per 2010 ACR/EULAR criteria, active disease (DAS28 ≥ 3.2), inadequate response or intolerance to at least one csDMARD, on a stable csDMARD regimen, able to consent and fluent in Dutch are ideal candidates.

Not a fit: Patients who have prior exposure to biological DMARDs, have contraindications to JAK inhibitors or TNF inhibitors, or who cannot attend visits in the Netherlands or communicate in Dutch are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, offering patients a choice of filgotinib or a TNF inhibitor could increase treatment satisfaction and adherence and may improve disease control, daily activity, and work productivity.

How similar studies have performed: Randomized trials have shown JAK inhibitors can match or exceed TNF inhibitors for symptom control and surveys suggest patients prefer oral JAK inhibitors, but randomized comparisons of patient-choice versus random assignment for satisfaction are limited.

Eligibility criteria

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 this trial is running

Leeuwarden

• 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

Conditions Rheumatoid Arthritis