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

Launched by R.BOS · Jul 30, 2021

Keywords

ClinConnect Summary

This clinical trial, called BACH, is studying treatment options for people with rheumatoid arthritis (RA), a condition that causes joint pain and swelling. The study wants to find out whether patients feel more satisfied and stick better to their treatment when they get to choose between two types of medicines: an oral medication called filgotinib (a JAK inhibitor) and injectable medicines called TNF inhibitors. Researchers will compare patients who pick their treatment with those who are randomly assigned to one of the two options to see which approach leads to better results and higher satisfaction.

Adults with active RA who have been on standard RA medicines without enough improvement may be eligible to join. Participants need to be at least 18 years old, able to understand Dutch, and have not used biological or JAK inhibitor treatments before. During the study, patients will receive either filgotinib or a TNF inhibitor and will be closely monitored for how well their symptoms improve, how active they are, and their ability to work. This study emphasizes the importance of shared decision-making between patients and doctors, aiming to help future RA treatments better match patients’ preferences and improve their quality of life.

Gender

ALL

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.