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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT06945666
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years old, male or female.
* Meets the classification criteria for rheumatoid arthritis established by the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) in 2010.
* Meeting any of the following treatment conditions with poor efficacy (DAS28 score as moderate-high disease activity) : receiving conventional DMARDs therapy such as methotrexate for at least 3 months; Treatment with biological agents such as TNFi for at least 3 months; Treatment with eramode or tofaciib alone for at least 3 months.
* Understand the procedure and content of the test, and voluntarily sign the informed consent.
Exclusion Criteria:
* Patients with a known allergy to Iguratimod or tofacitinib.
* Patients who have previously used eramode or tofaciib and discontinued treatment for safety reasons;
* At the time of screening, they are in the acute phase of acute infection or chronic infection;
* At screening, hepatitis B DNA and/or hepatitis C RNA screening is positive, indicating viral hepatitis, HBs only Ag-positive healthy carriers were not considered as exclusion criteria, and inclusion of the patient was determined by the investigator;
* At the time of screening, have a history of active TB or TB screening suggests latent infection with mycobacterium tuberculosis;
* A medical condition or history of congestive heart failure at the time of screening;
* Include other ongoing projects or studies;
* Severe, progressive, uncontrolled disorders of vital organs and systems, as well as other medical conditions Any circumstances that should not be included in this collection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06945666
Study Brief:
Protocol Section:
NCT06945666