NCT04985435RecruitingPhase 4

Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH)

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

Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Despite their efficacy in the treatment of Rheumatoid Arthritis and their partial advantage over traditional bDMARDs ( biological Disease Modifying antirheumatic drugs), JAK inhibitors (JAKi or tsDMARDs) have not gained preference over Tumor Necrosis Factor inhibitors (TNFi) in guidelines or clinical practice. The biggest influence on recent guidelines has been the "Treat To Target" principle (T2T), in which Shared Decision Making (SDM) plays a key part. Patient preference has proven to be a large barrier in treatment adjustments (14- 37%) while patients showed better adherence and higher treatment satisfaction when engaged in Shared Decision Making. From survey studies it is suggested that patient preference and satisfaction will be in favour of oral JAK inhibitors over parenteral biologics.The investigators want to establish the treatment preference of patients with active RA and compare the treatment satisfaction of patients who are given the opportunity to choose between the JAKi filgotinib and TNFi, to the treatment satisfaction of patients who are randomized to the same treatment options. In addition to higher treatment satisfaction and better adherence, the investigators expect to find an improvement in DAS28-, HAQ-, SQUASH- and WPAI-scores and also an improved activity and work productivity.

Status (registry): Recruiting
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 100 (estimated)
First submitted: 19 Jul 2021
Start date: 12 May 2021
Primary completion date: 30 Sept 2025
Lead sponsor: R.Bos
Diseases: Rheumatoid arthritis
NCT number: NCT04985435

What you commit to

Study type: Interventional · Phase 4
Planned participants: 100
From 12 May 2021 to the primary completion date, 30 Sept 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previous treatment with any biological DMARD or targeted synthetic DMARD/JAKi;

Other illness

Inflammatory rheumatic disease other than RA, except for secondary Sjögren's syndrome.
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;

Lab values

≥ 3x upper limit of normal ALT, AST;
eGFR ≤ 30 ml/min;

Other

Having a contraindication for either TNFi or filgotinib;
planned or actual pregnancy or planning to father a child.

Who the study is looking for

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.
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.

Age in the registry: 18 years to 101 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Medical Center Leeuwarden MCL Coordinator of this site? Confirm its status	Leeuwarden	Netherlands	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.