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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT04985435
• Date of registration: 19/07/2021
• Prospective Registration: No
• Primary sponsor: R.Bos
• Public title: Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH) BACH
• Scientific title: Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in Patients With Active Rheumatoid Arthritis (BACH)
• Date of first enrolment: May 12, 2021
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04985435
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Netherlands

Contacts

• Name: Reinhard Bos, MD PhD

• Name: Reinhard Bos, MD PhD

• Name: Reinhard Bos, MD PhD
• Affiliation: Rheumatology Research Center Northern Netherlands

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 101 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Filgotinib

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

Drug: Anti-Tumor Necrosis Factor Alpha Drug (Product)

Primary Outcome(s)

Treatment satisfaction at week 24 [Time Frame: 24 weeks]

The proportion of subjects in the first subgroup choosing filgotinib therapy at baseline [Time Frame: Baseline data]

Secondary Outcome(s)

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 patients rate being informed by the neutral information video [Time Frame: week 6 and week 24]

Proportion of patients who were not able to make a treatment decision. [Time Frame: baseline data]

Proportion of subjects who would choose filgotinib (again or otherwise) at 24-weeks if they were allowed to choose again. [Time Frame: week 24]

Secondary ID(s)

RTPO 1111

NL76371.099.21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Galapagos NV

Medical Centre Leeuwarden

Leiden University Medical Center