RECRUITINGPhase 4INTERVENTIONAL

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)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: Demographic and general characteristics: - Adult male or female patients, at least 18 years of age. - Able and willing to give written willing to sign a consent form. - Have sufficient knowledge of the Dutch language to be able to comply with the requirements of the study protocol. Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Filgotinib

200 mg tablet once daily or 100 mg once daily

DRUG

Anti-Tumor Necrosis Factor Alpha Drug (Product)

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

BEHAVIORAL

50 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