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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07349420
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 70 years.
* Diagnosis of rheumatoid arthritis according to the 2010 American College of - Rheumatology and European Alliance of Associations for Rheumatology classification criteria for at least 6 months.
* Moderate-to-severe active disease, defined as:
* Disease Activity Score in 28 joints using C-reactive protein at least 3.2 and not more than 6.0; and
* At least 6 tender joints and at least 6 swollen joints based on the 28-joint count.
* Inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (for example, methotrexate or leflunomide); and either:
* No prior biologic or targeted synthetic disease-modifying antirheumatic drug therapy; or
* No more than one prior line of biologic or targeted synthetic disease-modifying antirheumatic drug therapy, discontinued at least 12 weeks before screening.
* Stable background therapy:
* Conventional synthetic disease-modifying antirheumatic drug at a stable dose for at least 8 weeks; and
* Glucocorticoids at a dose not exceeding 10 milligrams per day of prednisone (or equivalent) at a stable dose for at least 4 weeks; and
* Nonsteroidal anti-inflammatory drugs and/or analgesics on a stable regimen for at least 2 weeks.
* Willingness and ability to comply with study visits, biospecimen collection, and contraception requirements (for women and men).
Exclusion Criteria:
* Current severe infection; active or latent tuberculosis without completed preventive therapy.
* Chronic hepatitis B, chronic hepatitis C, or human immunodeficiency virus infection with high viral load.
* Active malignancy or history of malignancy within 5 years, except adequately treated carcinoma in situ of the cervix or skin.
* History of severe opportunistic infections.
* Uncontrolled cardiovascular disease (including New York Heart Association class III or IV heart failure, acute coronary syndrome within the past 6 months, or uncontrolled arterial hypertension), decompensated diabetes mellitus, or severe liver or kidney disease.
* Pregnancy, breastfeeding, or planning pregnancy within 6 months.
* Prior treatment with cellular therapies, chimeric antigen receptor T-cell therapy, or profound immunosuppressive therapies with incomplete immune reconstitution.
* Any condition that, in the investigator's opinion, increases the risk of study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07349420
Study Brief:
Protocol Section:
NCT07349420