Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT04985435
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
101 Years
Study:
NCT04985435
Study Brief:
Protocol Section:
NCT04985435