RecruitingPhase 4NCT04985435

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)


Sponsor

R.Bos

Enrollment

100 participants

Start Date

May 12, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 101 Years

Plain Language Summary

Simplified for easier understanding

This Dutch trial (BACH) is comparing two treatments for rheumatoid arthritis (RA) — filgotinib (a targeted oral JAK inhibitor) versus a TNF inhibitor (a biologic injection) — and also looking at whether letting patients choose their own treatment leads to better outcomes than being randomly assigned. **You may be eligible if...** - You are 18 or older with a diagnosis of rheumatoid arthritis for at least 3 months - You have not responded well enough to at least one conventional DMARD (like methotrexate) - Your RA is moderately to severely active - You have never previously received a biologic or JAK inhibitor treatment - You are fluent in Dutch **You may NOT be eligible if...** - You have another inflammatory joint disease (except secondary Sjögren's) - You have active or latent tuberculosis - You have a history of cancer in the past 5 years - You are pregnant or planning a pregnancy - Your kidney or liver function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFilgotinib

200 mg tablet once daily or 100 mg once daily

DRUGAnti-Tumor Necrosis Factor Alpha Drug (Product)

Adalimumab subcutaneous injections 40 mg once every two weeks Etanercept subcutaneous injections 50 mg weekly

BEHAVIORAL50 patients will have a Free Choice between Filgotinib and anti TNF

50 patients will be given the opportunity to choose between either TNFi (etanercept 50 mg SC once a week or adalimumab 40 mg SC once every two weeks) or filgotinib, an oral JAKi, 200 mg once a day while another group of 50 patients will be randomized to the same treatment arms.


Locations(1)

Medical Center Leeuwarden MCL

Leeuwarden, Netherlands

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NCT04985435


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