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

August 4, 2025 updated by: R.Bos

Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in Patients With Active Rheumatoid Arthritis (BACH)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Reinhard Bos, MD PhD
  • Phone Number: 0031(0)582866104
  • Email: r.bos@mcl.nl

Study Contact Backup

Study Locations

  • Netherlands
      • Leeuwarden, Netherlands, 8934AD
        • Recruiting
        • Medical Center Leeuwarden MCL
        • Contact:
          • Reinhard Bos, MD PhD
          • Phone Number: 0031(0)582866104
          • Email: r.bos@mcl.nl
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 101 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Choice group
50 patients will be randomized to the choice group, they will view a neutral information video on anti TNF and Filgotinib and will be given the opportunity to choose between these two treatments
Drug: Filgotinib
200 mg tablet once daily or 100 mg once daily
Other Names:
  • Jyseleca
Drug: Anti-Tumor Necrosis Factor Alpha Drug (Product)
Adalimumab subcutaneous injections 40 mg once every two weeks Etanercept subcutaneous injections 50 mg weekly
Other Names:
  • Adalimumab (Humira) Etanercept (Enbrel)
Behavioral: 50 patients will have a Free Choice between Filgotinib and anti TNF
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.
Active Comparator: Randomization group anti TNF
A total of 50 patients will be randomized to the randomization group: 25 of those will start treatment with antiTNF
Drug: Anti-Tumor Necrosis Factor Alpha Drug (Product)
Adalimumab subcutaneous injections 40 mg once every two weeks Etanercept subcutaneous injections 50 mg weekly
Other Names:
  • Adalimumab (Humira) Etanercept (Enbrel)
Active Comparator: Randomization group Filgotinib
A total of 50 patients will be randomized to the randomization group: 25 of those will start treatment with Filgotinib
Drug: Filgotinib
200 mg tablet once daily or 100 mg once daily
Other Names:
  • Jyseleca

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of subjects in the first subgroup choosing filgotinib therapy at baseline
Time Frame: Baseline data
The proportion of subjects in the first subgroup choosing filgotinib therapy at baseline
Baseline data
Treatment satisfaction at week 24
Time Frame: 24 weeks
Treatment satisfaction of both subgroups at week 24 at 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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
How patients rate being informed by the neutral information video
Time Frame: week 6 and week 24
How patients rate being informed by the neutral information video on a Likert scale of agreement on being well informed, ranging from 1: strongly disagree, 2: disagree, 3: undecided, 4: agree, 5: strongly agree
week 6 and week 24
How do patients in the treatment Choice group I rate being in control for their treatment decision.
Time Frame: week 6 and week 24
How do patients in the treatment Choice group I rate being in control for their treatment decision.
week 6 and week 24
Proportion of subjects who would choose filgotinib (again or otherwise) at 24-weeks if they were allowed to choose again.
Time Frame: week 24
Proportion of subjects who would choose filgotinib (again or otherwise) at 24-weeks if they were allowed to choose again.
week 24
Proportion of patients who were not able to make a treatment decision.
Time Frame: baseline data
Proportion of patients who were not able to make a treatment decision.
baseline data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R.Bos

Collaborators

Leiden University Medical Center
Galapagos NV
Frisius Medisch Centrum

Investigators

  • Principal Investigator: Reinhard Bos, MD PhD, Rheumatology Research Center Northern Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTPO 1111
  • NL76371.099.21 (Other Identifier: CCMO ABR number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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