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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT06046950
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of RA (according to the 2010 or 1987 ACR/ EULAR classification criteria and/or clinical diagnosis)
* (Starting) use of a DMARD
* Aged 16 years or older
* At most low disease activity, operationalised as DAS28-CRP \<3.5 (DAS28 CRP 2.9 cut off for low disease activity with measurement error 0.6) or SDAI \<19 (SDAI 11 cut off for low disease activity with measurement error of 8). A state of low disease activity is required at inclusion, as for RA patients in moderate or high disease activity there is no equipoise on the best course of action (treatment needs to be escalated).
* Fluency of Dutch or English, both written and verbally; able to fill in questionnaires
* Provided informed consent
Exclusion Criteria:
* Clinical deep remission, operationalised as SDAI \<3.3 or DAS28-CRP \<2.4, and an taper attempt in the past 2 years that was discontinued due to occurrence of flare.
* Fewer than 3 DMARD treatment options left for this patient (severe difficult-to-treat or refractory RA)
* Current severe comorbidity or other serious life-shortening conditions hampering trial participation
* Inability to comply with the study protocol or to provide informed consent with regard to intervention control and measuring outcomes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT06046950
Study Brief:
Protocol Section:
NCT06046950