Rheumatoid ArthritisPhase 4BACHNCT04985435
Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH)
A Phase 4 study testing Filgotinib, Anti-Tumor Necrosis Factor Alpha Drug (Product) and 50 patients will have a Free Choice between Filgotinib and anti TNF in people with Rheumatoid Arthritis, run by R.Bos at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Filgotinib, Anti-Tumor Necrosis Factor Alpha Drug (Product) and 50 patients will have a Free Choice between Filgotinib and anti TNF
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 May 2021to 30 Sep 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Diagnosis of adult-onset RA as defined by the 2010 ACR/ EULAR Rheumatoid arthritis classification criteria;
- Diagnosis of RA for ≥ three months;
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- ≥ 3x upper limit of normal ALT, AST;
- eGFR ≤ 30 ml/min;
- planned or actual pregnancy or planning to father a child.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Medical Center Leeuwarden MCL
Leeuwarden, 8934AD
Reinhard Bos, MD PhD, 0031(0)582866104, r.bos@mcl.nl
Floor L Reimann, MD, 0031(0)582866104, floor.reimann@mcl.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Filgotinib, Anti-Tumor Necrosis Factor Alpha Drug (Product), 50 patients will have a Free Choice between Filgotinib and anti TNF
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
Also called Jyseleca
200 mg tablet once daily or 100 mg once daily
Anti-Tumor Necrosis Factor Alpha Drug (Product)Drug
Also called Adalimumab (Humira) Etanercept (Enbrel)
Adalimumab subcutaneous injections 40 mg once every two weeks Etanercept subcutaneous injections 50 mg weekly
50 patients will have a Free Choice between Filgotinib and anti TNFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Choice group | Active comparator | 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 Receives: Drug: Filgotinib; Drug: Anti-Tumor Necrosis Factor Alpha Drug (Product); Behavioral: 50 patients will have a Free Choice between Filgotinib and anti TNF |
| Randomization group anti TNF | Active comparator | A total of 50 patients will be randomized to the randomization group: 25 of those will start treatment with antiTNF Receives: Drug: Anti-Tumor Necrosis Factor Alpha Drug (Product) |
| Randomization group Filgotinib | Active comparator | A total of 50 patients will be randomized to the randomization group: 25 of those will start treatment with Filgotinib Receives: Drug: Filgotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects in the first subgroup choosing filgotinib therapy at baseline
The proportion of subjects in the first subgroup choosing filgotinib therapy at baseline
Measured: Baseline data
Treatment satisfaction at week 24
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.
Measured: 24 weeks
Secondary outcomes (4)
How patients rate being informed by the neutral information video
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
Measured: week 6 and week 24
How do patients in the treatment Choice group I rate being in control for their treatment decision.
How do patients in the treatment Choice group I rate being in control for their treatment decision.
Measured: 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.
Proportion of subjects who would choose filgotinib (again or otherwise) at 24-weeks if they were allowed to choose again.
Measured: week 24
Proportion of patients who were not able to make a treatment decision.
Proportion of patients who were not able to make a treatment decision.
Measured: baseline data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start12 May 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized open label trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R.Bos
- Sponsor type
- University, hospital or other
- Collaborators
- Lakefront Biotherapeutics NV, Frisius Medisch Centrum, Leiden University Medical Center
- Responsible party
- Sponsor-investigator, R.Bos, Rheumatology Research Center Northern Netherlands
- Investigators
- Reinhard Bos, MD PhD, Principal investigator, Rheumatology Research Center Northern Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985435
- Sponsor's protocol ID
- RTPO 1111
- Other IDs
- NL76371.099.21
- Acronym
- BACH
- Status last verified
- Aug 2025
- First submitted
- 19 Jul 2021
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zak A, Corrigan C, Yu Z, Bitton A, Fraenkel L, Harrold L, Smolen JS, Solomon DH. Barriers to treatment adjustment within a treat to target strategy in rheumatoid arthritis: a secondary analysis of the TRACTION trial. Rheumatology (Oxford). 2018 Nov 1;57(11):1933-1937. doi: 10.1093/rheumatology/key179.
PubMed 29982720Schipper LG, Vermeer M, Kuper HH, Hoekstra MO, Haagsma CJ, Den Broeder AA, van Riel P, Fransen J, van de Laar MA. A tight control treatment strategy aiming for remission in early rheumatoid arthritis is more effective than usual care treatment in daily clinical practice: a study of two cohorts in the Dutch Rheumatoid Arthritis Monitoring registry. Ann Rheum Dis. 2012 Jun;71(6):845-50. doi: 10.1136/annrheumdis-2011-200274. Epub 2011 Dec 30.
PubMed 22210852Tymms K, Zochling J, Scott J, Bird P, Burnet S, de Jager J, Griffiths H, Nicholls D, Roberts L, Arnold M, Littlejohn G. Barriers to optimal disease control for rheumatoid arthritis patients with moderate and high disease activity. Arthritis Care Res (Hoboken). 2014 Feb;66(2):190-6. doi: 10.1002/acr.22108.
PubMed 23983001Lofland JH, Johnson PT, Ingham MP, Rosemas SC, White JC, Ellis L. Shared decision-making for biologic treatment of autoimmune disease: influence on adherence, persistence, satisfaction, and health care costs. Patient Prefer Adherence. 2017 May 18;11:947-958. doi: 10.2147/PPA.S133222. eCollection 2017.
PubMed 28572722Alten R, Kruger K, Rellecke J, Schiffner-Rohe J, Behmer O, Schiffhorst G, Nolting HD. Examining patient preferences in the treatment of rheumatoid arthritis using a discrete-choice approach. Patient Prefer Adherence. 2016 Nov 1;10:2217-2228. doi: 10.2147/PPA.S117774. eCollection 2016.
PubMed 27843301Schiffner-Rohe J, Alten R, Kruger K, Behmer OS, Schiffhorst G, Rellecke J, Nolting HD. Patient Preferences in the Choice of Disease Modifying Anti-Rheumatic Drugs. Value Health. 2014 Nov;17(7):A385. doi: 10.1016/j.jval.2014.08.2641. Epub 2014 Oct 26. No abstract available.
PubMed 27200872Taylor PC, Betteridge N, Brown TM, Woolcott J, Kivitz AJ, Zerbini C, Whalley D, Olayinka-Amao O, Chen C, Dahl P, Ponce de Leon D, Gruben D, Fallon L. Treatment Mode Preferences in Rheumatoid Arthritis: Moving Toward Shared Decision-Making. Patient Prefer Adherence. 2020 Jan 20;14:119-131. doi: 10.2147/PPA.S220714. eCollection 2020.
PubMed 32021123Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, Zwinderman AH, Ronday HK, Han KH, Westedt ML, Gerards AH, van Groenendael JH, Lems WF, van Krugten MV, Breedveld FC, Dijkmans BA. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum. 2005 Nov;52(11):3381-90. doi: 10.1002/art.21405.
PubMed 16258899van Eijk IC, Nielen MM, van der Horst-Bruinsma I, Tijhuis GJ, Boers M, Dijkmans BA, van Schaardenburg D. Aggressive therapy in patients with early arthritis results in similar outcome compared with conventional care: the STREAM randomized trial. Rheumatology (Oxford). 2012 Apr;51(4):686-94. doi: 10.1093/rheumatology/ker355. Epub 2011 Dec 13.
PubMed 22166255Schipper LG, van Hulst LT, Grol R, van Riel PL, Hulscher ME, Fransen J. Meta-analysis of tight control strategies in rheumatoid arthritis: protocolized treatment has additional value with respect to the clinical outcome. Rheumatology (Oxford). 2010 Nov;49(11):2154-64. doi: 10.1093/rheumatology/keq195. Epub 2010 Jul 29.
PubMed 20671022Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Kerstens PJ, Nielen MM, Vos K, van Schaardenburg D, Speyer I, Seys PE, Breedveld FC, Allaart CF, Dijkmans BA. DAS-driven therapy versus routine care in patients with recent-onset active rheumatoid arthritis. Ann Rheum Dis. 2010 Jan;69(1):65-9. doi: 10.1136/ard.2008.097683.
PubMed 19155234Smolen JS, Breedveld FC, Burmester GR, Bykerk V, Dougados M, Emery P, Kvien TK, Navarro-Compan MV, Oliver S, Schoels M, Scholte-Voshaar M, Stamm T, Stoffer M, Takeuchi T, Aletaha D, Andreu JL, Aringer M, Bergman M, Betteridge N, Bijlsma H, Burkhardt H, Cardiel M, Combe B, Durez P, Fonseca JE, Gibofsky A, Gomez-Reino JJ, Graninger W, Hannonen P, Haraoui B, Kouloumas M, Landewe R, Martin-Mola E, Nash P, Ostergaard M, Ostor A, Richards P, Sokka-Isler T, Thorne C, Tzioufas AG, van Vollenhoven R, de Wit M, van der Heijde D. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis. 2016 Jan;75(1):3-15. doi: 10.1136/annrheumdis-2015-207524. Epub 2015 May 12.
PubMed 25969430Smolen JS, Landewe RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, McInnes IB, Sepriano A, van Vollenhoven RF, de Wit M, Aletaha D, Aringer M, Askling J, Balsa A, Boers M, den Broeder AA, Buch MH, Buttgereit F, Caporali R, Cardiel MH, De Cock D, Codreanu C, Cutolo M, Edwards CJ, van Eijk-Hustings Y, Emery P, Finckh A, Gossec L, Gottenberg JE, Hetland ML, Huizinga TWJ, Koloumas M, Li Z, Mariette X, Muller-Ladner U, Mysler EF, da Silva JAP, Poor G, Pope JE, Rubbert-Roth A, Ruyssen-Witrand A, Saag KG, Strangfeld A, Takeuchi T, Voshaar M, Westhovens R, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):685-699. doi: 10.1136/annrheumdis-2019-216655. Epub 2020 Jan 22.
PubMed 31969328Louder AM, Singh A, Saverno K, Cappelleri JC, Aten AJ, Koenig AS, Pasquale MK. Patient Preferences Regarding Rheumatoid Arthritis Therapies: A Conjoint Analysis. Am Health Drug Benefits. 2016 Apr;9(2):84-93.
PubMed 27182427Barton JL. Patient preferences and satisfaction in the treatment of rheumatoid arthritis with biologic therapy. Patient Prefer Adherence. 2009 Nov 29;3:335-44. doi: 10.2147/ppa.s5835.
PubMed 20016797
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in Patients With Active Rheumatoid Arthritis (BACH)
- ClinicalTrials.gov ID
- NCT04985435
- Acronym / sponsor ID
- BACH / RTPO 1111
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- R.BosUniversity, hospital or other
- Collaborators
- Lakefront Biotherapeutics NV, Frisius Medisch Centrum, Leiden University Medical Center
- Study start
- 12 May 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized open label trial
| Arm | Type | Receives |
|---|---|---|
| Choice group | Active comparator | Drug: Filgotinib, Drug: Anti-Tumor Necrosis Factor Alpha Drug (Product), Behavioral: 50 patients will have a Free Choice between Filgotinib and anti TNF50 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 |
| Randomization group anti TNF | Active comparator | Drug: Anti-Tumor Necrosis Factor Alpha Drug (Product)A total of 50 patients will be randomized to the randomization group: 25 of those will start treatment with antiTNF |
| Randomization group Filgotinib | Active comparator | Drug: FilgotinibA total of 50 patients will be randomized to the randomization group: 25 of those will start treatment with Filgotinib |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Diagnosis of adult-onset RA as defined by the 2010 ACR/ EULAR Rheumatoid arthritis classification criteria;
- Diagnosis of RA for ≥ three months;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgotinibAlso: Jyseleca200 mg tablet once daily or 100 mg once daily | Drug | Choice group, Randomization group Filgotinib |
| Anti-Tumor Necrosis Factor Alpha Drug (Product)Also: Adalimumab (Humira) Etanercept (Enbrel)Adalimumab subcutaneous injections 40 mg once every two weeks Etanercept subcutaneous injections 50 mg weekly | Drug | Choice group, Randomization group anti TNF |
| 50 patients will have a Free Choice between Filgotinib and anti TNF50 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. | Behavioural | Choice group |
Primary outcome
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
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.
4 secondary outcomes
How patients rate being informed by the neutral information video
Time frame: 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
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 patients who were not able to make a treatment decision.
Time frame: baseline data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 29982720Zak A, Corrigan C, Yu Z, Bitton A, Fraenkel L, Harrold L, Smolen JS, Solomon DH. Barriers to treatment adjustment within a treat to target strategy in rheumatoid arthritis: a secondary analysis of the TRACTION trial. Rheumatology (Oxford). 2018 Nov 1;57(11):1933-1937. doi: 10.1093/rheumatology/key179.
- Background: PubMed 22210852Schipper LG, Vermeer M, Kuper HH, Hoekstra MO, Haagsma CJ, Den Broeder AA, van Riel P, Fransen J, van de Laar MA. A tight control treatment strategy aiming for remission in early rheumatoid arthritis is more effective than usual care treatment in daily clinical practice: a study of two cohorts in the Dutch Rheumatoid Arthritis Monitoring registry. Ann Rheum Dis. 2012 Jun;71(6):845-50. doi: 10.1136/annrheumdis-2011-200274. Epub 2011 Dec 30.
- Background: PubMed 23983001Tymms K, Zochling J, Scott J, Bird P, Burnet S, de Jager J, Griffiths H, Nicholls D, Roberts L, Arnold M, Littlejohn G. Barriers to optimal disease control for rheumatoid arthritis patients with moderate and high disease activity. Arthritis Care Res (Hoboken). 2014 Feb;66(2):190-6. doi: 10.1002/acr.22108.
- Background: PubMed 28572722Lofland JH, Johnson PT, Ingham MP, Rosemas SC, White JC, Ellis L. Shared decision-making for biologic treatment of autoimmune disease: influence on adherence, persistence, satisfaction, and health care costs. Patient Prefer Adherence. 2017 May 18;11:947-958. doi: 10.2147/PPA.S133222. eCollection 2017.
- Background: PubMed 27843301Alten R, Kruger K, Rellecke J, Schiffner-Rohe J, Behmer O, Schiffhorst G, Nolting HD. Examining patient preferences in the treatment of rheumatoid arthritis using a discrete-choice approach. Patient Prefer Adherence. 2016 Nov 1;10:2217-2228. doi: 10.2147/PPA.S117774. eCollection 2016.
- Background: PubMed 27200872Schiffner-Rohe J, Alten R, Kruger K, Behmer OS, Schiffhorst G, Rellecke J, Nolting HD. Patient Preferences in the Choice of Disease Modifying Anti-Rheumatic Drugs. Value Health. 2014 Nov;17(7):A385. doi: 10.1016/j.jval.2014.08.2641. Epub 2014 Oct 26. No abstract available.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reinhard Bos, MD PhD principal investigator
Rheumatology Research Center Northern Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Filgotinib, Anti-Tumor Necrosis Factor Alpha Drug (Product) and 50 patients will have a Free Choice between Filgotinib and anti TNF in people with Rheumatoid Arthritis, run by R.Bos at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reinhard Bos, MD PhD (0031(0)582866104, r.bos@mcl.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects in the first subgroup choosing filgotinib therapy at baseline (time frame: Baseline data). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985435, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.