Actively Recruiting
Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH)
Led by R.Bos · Updated on 2025-08-08
100
Participants Needed
1
Research Sites
228 weeks
Total Duration
On this page
Sponsors
R
R.Bos
Lead Sponsor
G
Galapagos NV
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female patients, at least 18 years old
- Able and willing to give written informed consent
- Sufficient knowledge of Dutch to comply with study requirements
- Diagnosis of adult-onset Rheumatoid Arthritis by 2010 ACR/EULAR criteria
- Diagnosis of RA for at least 3 months
- Treated at least 3 months with one or more conventional synthetic DMARDs
- Inadequate response or intolerance to at least one csDMARD
- Moderately to severely active RA, defined by rheumatologist or DAS28 score 3.2 or higher
- Stable dose of csDMARD therapy (methotrexate, chloroquine, hydroxychloroquine, sulfasalazine, or leflunomide) for at least 4 weeks before baseline
You will not qualify if you...
- Previous treatment with any biological DMARD or targeted synthetic DMARD/JAK inhibitor
- Inflammatory rheumatic diseases other than RA except secondary Sj�f6gren's syndrome
- Contraindication for TNFi or filgotinib
- Latent or active tuberculosis
- Active or recurrent infections
- History of malignancy within 5 years except treated non-melanoma skin cancer or localized carcinoma in situ of cervix
- Liver enzymes ALT or AST more than 3 times upper normal limit
- Estimated glomerular filtration rate 30 ml/min or less
- Current or planned pregnancy or planning to father a child
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical Center Leeuwarden MCL
Leeuwarden, Netherlands, 8934AD
Actively Recruiting
Research Team
R
Reinhard Bos, MD PhD
CONTACT
F
Floor L Reimann, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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