Rheumatoid Arthritis
Conditions
Interventions
BACH is an open label trial where a total of 100 patients who meet the eligibility criteria and agree to participate will be randomized 1:1 into two groups of 50 patients:
- Group I: The “Choice Group
Sponsors
investigator initiated trial by Rheumatology Research Center Northern Netherlands
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group I -The proportion of subjects choosing filgotinib at baseline. Total study population, Group I versus Group II: -Treatment satisfaction at week 24 on a 5-point Likert scale for current medical treatment ranging from 1: very dissatisfied, 2: dissatisfied, 3: neither dissatisfied nor satisfied, 4: satisfied, 5: very satisfied. | — |
Secondary
| Measure | Time frame |
|---|---|
| Group I - How patients rate being informed by the neutral information video on a Likert scale of agreement on being well informed, after 6 weeks and at week 24. - How do patients in the treatment Choice group I rate being in control for their treatment decision at week 6 and at week 24. - Proportion of subjects who would choose filgotinib (again or otherwise) at 24-weeks if they were allowed to choose again; - Proportion of patients who were not able to make a treatment decision. Total study population: - Adherence measurements by 5-item Self-Reported Medication Adherence Report Scale (MARS-5) at weeks 0, 6, 12, 18 and 24. - Change from Baseline of Disease Activity Score (DAS28) and physical activity as measured by SQUASH questionnaire and fitness tracker (daily footsteps, speed of acceleration, mean heart beat) at weeks 6, 12 and 24. - Time to remission by both PROMs and DAS28 (with remission defined as DAS28 <2.6). And a comparison of percentage of remission for Group I JAKi- and TNFi-, Group II JAKi- and TNFi-subgroups at weeks 6, 12, 18, 24. - Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at week 12 and 24. - Change from baseline in Work Productivity and Activity Impairment (WPAI) at Weeks 6, 12, and 24. - Registration of concomitant medication use (NSAIDs, analgesics, other DMARDs, i.a. and i.m. corticosteroid injections). - Weekly number of footsteps and improvement of DAS28 at the next visit - Actual preference of the treating rheumatologists when they decide which mode of action for treatment of each rheumatoid arthritis patient they would have chosen: Percentages of either filgotinib or TNFi. - To evaluate which factors contribute to a difference in treatment choice between patient and rheumatologist (mode of administration, comorbidity, side effects, patient-peer information) | — |
Contacts
Public ContactFloor Reimann
Medical Center Leeuwarden/ Rheumatology Research Center Northern Netherlands
Outcome results
None listed