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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT07147959
Eligibility Criteria:
Inclusion Criteria:
* Female (of non-childbearing potential) or male between 60-85 years of age (both inclusive).
* For male participants with female partners of child-bearing potential, an adequate form of contraception must be adhered to, and men must refrain from donating sperm, prior to entry into the trial and for a further 6 months after IP administration.
* Willing and able to provide written, informed consent.
Exclusion Criteria:
* Diagnosed with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 6 months prior to screening (diagnosis based on medical records).
Participants in Cohort A (active RA) must furthermore meet the following criteria:
\- Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) (DAS28-CRP) ≥ 4.2 AND ≥ 1 Swollen Joint AND ≥ 1 Tender Joint prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT07147959
Study Brief:
Protocol Section:
NCT07147959