primary objectives- 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 choose…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
<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)
Patient characteristics will be evaluated to describe the population and use as
covariables in statistical analysis or to calculate disease activity scores.
See section 8.1.3 of the protocol
Background summary
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
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. We want to evaluate the treatment preference of
patients when they are given the opportunity to choose between oral treatment
with the JAKi Filgotinib and subcutaneous injections TNFi. The study also
compares the difference in treatment satisfaction between patients who can
choose their own treatment and patients who are randomized to the same
treatment options.
In addition to higher treatment satisfaction and better adherence, we expect to
find an improvement in DAS28-, HAQ-, SQUASH- and WPAI-scores and also an
improved activity and work productivity.
Study objective
primary objectives
- 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 choose
their own therapy and those patients that are randomized to the same treatment
options.
secondary Objectives:
Group I:
- To evaluate how patients rate being informed by the neutral information video
on a Likert scale of agreement on being well informed, at week 6 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.
Total study population:
- To evaluate if therapy adherence is increased when patients are allowed to
decide their own therapy compared to patients who are randomized to the same
treatment options.
- To evaluate the difference in improvement of disease activity by the Disease
Activity Score (DAS28) and physical activity as measured by SQUASH
questionnaire and fitnesstracker (pedometer, accelerometer, heart beat).
- To compare time to remission for Group I and II, and for TNFi users in the
Choice group and those in the Randomization group and between JAKi users in the
Choice group and those in the Randomization group.
- To compare the difference in improvement of the objective components of the
DAS 28 ( SJC, CRP/ BSE) to the improvement in the (more) subjective components;
VAS or TJC.
- To compare adherence to medication between Choice and Randomization groups.
- Compare adherence to medication between TNFi users in the Choice group and
those in the Randomization group and between JAKi users in the Choice group and
those in the Randomization group.
- To evaluate the weekly reported number of footsteps as an early predictor of
improvement of DAS28 at the next visit
- To evaluate the difference in improvement of HAQ , WPAI and SF-36 scores with
physical activity as measured by SQUASH and fitness tracker (pedometer,
accelerometer, heart beat).
- To evaluate the actual preference of the treating rheumatologists when they
decide which mode of action for treatment of each rheumatoid arthritis patient
they would have chosen.
- To evaluate which factors contribute to a difference in treatment choice
between patient and rheumatologist ( comorbidity, personal preference, hospital
preference for TNFi)
Study design
This multicenter study with a 24-week treatment period is designed to evaluate
the treatment preference of patients when they are given the opportunity to
choose between oral treatment with the JAKi Filgotinib and subcutaneous
injections TNFi. The study also compares the difference in treatment
satisfaction between patients who can choose their own treatment and patients
who are randomized to the same treatment options.
BACH is an open label trial with a total of 100 patients. 50 patients will be
randomized for to two treatment options (JAKi or TNFi) and another 50 can
choose their treatment out of the same options.
This study will have a multicenter design in the Netherlands. Adult patients
with active RA who had insufficient therapeutic effect on a conventional DMARD
(csDMARD non-responders) or who have a contra-indication to a csDMARD visiting
the outpatient rheumatology clinics of the participating centers will be
invited to participate in the study.
Intervention
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 subcutaneous injection
Adalimumab 40 mg every two weeks or one subcutaneous injection etanercept 50 mg
every week, depending on hospital policy of the individual centers)
Group II: N= 50 subjects who will be randomized for the same treatment options
as group I: treatment with Filgotinib ( one oral tablet once daily 200 mg) or
TNFi (one subcutaneous injection Adalimumab 40 mg every two weeks or one
subcutaneous injection etanercept 50 mg every week, depending on hospital
policy of the individual centers)
**conform regular care: if a patient is > 75 and or has an eGFR < 60 a dose
reduction of filgotinib to 1 dd 100 mg has to follow
Study burden and risks
All medication is prescribed at the indicated dosages used in clinical care,
according to international guidelines.
Study burden and risks are deemed acceptable and similar to daily clinical
care:
- questionnaires will take about 10-30 minutes to complete (depending on the
visit).
- DAS 28 joint score is standard RA care
- blood withdrawal will be as in normal clinical practice while starting TNFi
or JAKi
henri dunantweg 2
Leeuwarden 8934AD
NL
henri dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
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
- 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 <= 30 ml/min;
- planned or actual pregnancy or planning to father a child.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76371.099.21 |