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

NCT04985435 | Recruiting Phase 4

• 2 other identifiers: RTPO 1111NL76371.099.21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  24 weeks

Secondary Outcomes (4)

• How patients rate being informed by the neutral information video

  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.

  week 24

• Proportion of patients who were not able to make a treatment decision.

  baseline data

Study Arms (3)

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

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

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

Drug: Filgotinib

Interventions

Filgotinib DRUG

200 mg tablet once daily or 100 mg once daily

Also known as: Jyseleca

Choice group; Randomization group Filgotinib

Anti-Tumor Necrosis Factor Alpha Drug (Product) DRUG

Adalimumab subcutaneous injections 40 mg once every two weeks Etanercept subcutaneous injections 50 mg weekly

Also known as: Adalimumab (Humira) Etanercept (Enbrel)

Choice group; Randomization group anti TNF

50 patients will have a Free Choice between Filgotinib and anti TNF BEHAVIORAL

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.

Choice group

Eligibility Criteria

• Age: 18 Years - 101 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• R.Bos: lead
• Galapagos NV: collaborator
• Frisius Medisch Centrum: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

Medical Center Leeuwarden MCL

Leeuwarden, 8934AD, Netherlands

RECRUITING

Related Publications (22)

• 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.

  PMID: 29982720 BACKGROUND

• Schipper 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.

  PMID: 22210852 BACKGROUND

• Tymms 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.

  PMID: 23983001 BACKGROUND

• Lofland 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.

  PMID: 28572722 BACKGROUND

• Alten 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.

  PMID: 27843301 BACKGROUND

• Schiffner-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.

  PMID: 27200872 BACKGROUND

• Taylor 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.

  PMID: 32021123 BACKGROUND

• Goekoop-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.

  PMID: 16258899 BACKGROUND

• van 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.

  PMID: 22166255 BACKGROUND

• Schipper 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.

  PMID: 20671022 BACKGROUND

• Goekoop-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.

  PMID: 19155234 BACKGROUND

• Smolen 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.

  PMID: 25969430 BACKGROUND

• Smolen 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.

  PMID: 31969328 BACKGROUND

• Louder 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.

  PMID: 27182427 BACKGROUND

• Barton 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.

  PMID: 20016797 BACKGROUND

• Raghunath S, Hijjawi R, Hoon E, Shanahan EM, Goldblatt F. Qualitative assessment of medication adherence in patients with rheumatic diseases on biologic therapy. Clin Rheumatol. 2019 Oct;38(10):2699-2707. doi: 10.1007/s10067-019-04609-y. Epub 2019 Jun 6.

  PMID: 31172365 BACKGROUND

• Stalpers J. Psychological Determinants of Subjective health. Doctoral dissertation, Nyenrode Business Universiteit, The Netherlands. Nyenrode Business Universiteit. Doctoral dissertation, Nyenrode Business Universiteit, The Netherlands 2009;.

  BACKGROUND

• Nota I, Drossaert CH, Taal E, van de Laar MA. Arthritis patients' motives for (not) wanting to be involved in medical decision-making and the factors that hinder or promote patient involvement. Clin Rheumatol. 2016 May;35(5):1225-35. doi: 10.1007/s10067-014-2820-y. Epub 2014 Nov 14.

  PMID: 25392118 BACKGROUND

• Schildmann J, Grunke M, Kalden JR, Vollmann J. Information and participation in decision-making about treatment: a qualitative study of the perceptions and preferences of patients with rheumatoid arthritis. J Med Ethics. 2008 Nov;34(11):775-9. doi: 10.1136/jme.2007.023705.

  PMID: 18974408 BACKGROUND

• Mattukat K, Boehm P, Raberger K, Schaefer C, Keyszer G, Mau W. How Much Information and Participation Do Patients with Inflammatory Rheumatic Diseases Prefer in Interaction with Physicians? Results of a Participatory Research Project. Patient Prefer Adherence. 2019 Dec 17;13:2145-2158. doi: 10.2147/PPA.S209346. eCollection 2019.

  PMID: 31908422 BACKGROUND

• Bloem S, Stalpers J, Groenland EAG, van Montfort K, van Raaij WF, de Rooij K. Segmentation of health-care consumers: psychological determinants of subjective health and other person-related variables. BMC Health Serv Res. 2020 Aug 8;20(1):726. doi: 10.1186/s12913-020-05560-4.

  PMID: 32771005 BACKGROUND

• Lee YH, Song GG. Relative efficacy and safety of tofacitinib, baricitinib, upadacitinib, and filgotinib in comparison to adalimumab in patients with active rheumatoid arthritis. Z Rheumatol. 2020 Oct;79(8):785-796. doi: 10.1007/s00393-020-00750-1.

  PMID: 32055928 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

GLPG0634; Pharmaceutical Preparations; Adalimumab; Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Reinhard Bos, MD PhD

  Rheumatology Research Center Northern Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reinhard Bos, MD PhD

CONTACT

0031(0)582866104; r.bos@mcl.nl

Floor L Reimann, MD

CONTACT

0031(0)582866104; floor.reimann@mcl.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal (coordinating) investigator

Model Details: randomized open label trial

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 2, 2021
• Study Start: May 12, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)