RA rheuma rheumatoid arthritis
Conditions
Interventions
100 patients will be randomized into two groups of 50 patients:
Group I: N=50 subjects are given the choice between treatment with Filgotinib
(one oral tablet once daily 200 mg) or TNFi (one subcutan
Sponsors
Medisch Centrum Leeuwarden MCL/ Rheumatology Research Center Northern Netherlands
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Demographic and general characteristics: - Adult male or female patients, 18-65 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 or low dose prednisone) for >= 4 weeks prior to the baseline visit. An IM corticosteroid injection or tapering schedule at the start of the study (because the patients arthritis might otherwise be too severe for too long) is not encouraged but considered to be at the discretion of the local PI and can be discussed with the studyteam.
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; - Significantly increased risk of major cardiovascular problems (such as heart attack or stroke) - Current smoker or have done so for a long time in the past - significantly increased risk of cancer - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoints: - the proportion of subjects choosing Filgotinib therapy at baseline - treatment satisfaction at week 24 at a 5-point Likert scale for current medical treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| See section 8.1.2 of the protocol 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 | — |
Countries
Netherlands
Outcome results
None listed