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

  • STATUS
    Recruiting
  • End date
    Apr 9, 2023
  • participants needed
    100
  • sponsor
    R.Bos
Updated on 9 August 2021
methotrexate
adalimumab
tumor necrosis factor
etanercept
hydroxychloroquine
DMARD
tumor necrosis factor alpha
sulfasalazine
tumour necrosis
leflunomide
chloroquine
antirheumatics
tumor necrosis factor inhibitors

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.

Description

Rationale: Despite their efficacy in the treatment of Rheumatoid Arthritis and their partial advantage over traditional bDMARDs, 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.

Objective
  • To evaluate the actual preference of patients when they decide themselves which mode of action they want to use for treatment of rheumatoid arthritis.
  • To evaluate differences in treatment satisfaction between patients who can choose their therapy and those patients that are randomized for the same treatment options.
  • To evaluate if adherence to therapy is increased when patients decide their own therapy.
  • To evaluate the difference in improvement of disease activity by the Disease Activity Score (DAS28) and physical activity as measured by SQUASH questionnaire and fitness trackers.

Study design: This study is a multicenter, randomized, 24-week, open label trial

Study population and intervention:

Early, bDMARD naive RA patients, of whom a group of 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.

Main study parameters/endpoints: The two primary endpoints consist of:

  • The proportion of subjects in the first subgroup choosing filgotinib therapy at baseline
  • Treatment satisfaction of both subgroups at week 24 at a 5-point Likert scale for current medical treatment.

Burden and risks associated with participation, benefit and group relatedness: All medication is prescribed at the indicated dosages used in clinical care, according to international guidelines. Study burden and risks are similar to daily clinical care: In addition to daily clinical care one half of the participants has to make the treatment choice and all participants will fill in questionnaires, which will take about 15 minutes to complete.

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric)
Treatment Filgotinib, Anti-Tumor Necrosis Factor Alpha Drug (Product), Anti-Tumor Necrosis Factor Alpha Drug (Product), 50 patients will have a Free Choice between Filgotinib and anti TNF
Clinical Study IdentifierNCT04985435
SponsorR.Bos
Last Modified on9 August 2021

Eligibility

Yes No Not Sure

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 Sjgren'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
x upper limit of normal ALT, AST
eGFR 30 ml/min
planned or actual pregnancy or planning to father a child
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