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:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT01602302
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient ≥18 years and \<90 years of age
* Classification of RA according to the ACR/EULAR 2010 criteria
* Persistent clinical remission as defined by the ACR/EULAR remission criteria for at least 6 months (documented at ≥2 visits)
* Written informed consent
* Current treatment with a single csDMARD or a combination of csDMARDs plus a stable dose and administration interval (for the last 6 months) of a TNF-alpha inhibitor
* No current systemic corticosteroid treatment (stopped for at least 4 weeks), no corticosteroid injection within 4 weeks
* Stable dose of NSAIDs for at least 1 week
Exclusion Criteria:
* • Current treatment with any investigational drug
* Current administration interval of the anti-TNF-alpha agent of \>11 weeks
* Complete destruction of any joint to be investigated by sonography
* Current RA-related vasculitis or other active systemic (i.e. extraarticular) RA- manifestation with the exception of rheumatoid nodules
* Initial arthritis manifestations before the age of 17 years
* Planned surgery within the study period or history of surgery of any of the joints to be investigated clinically or by sonography
* Current severe medical illness requiring hospitalization
* Active infection or active malignancy at screening or infection during the past 4 weeks requiring (even temporary) discontinuation of the anti-TNF-alpha agent
* Pregnancy or lactation
* Inability of the patient to follow the protocol
* Current treatment with Rituximab (MabThera®)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01602302
Study Brief:
Protocol Section:
NCT01602302