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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT01096069
Eligibility Criteria:
Inclusion Criteria:
1. Patients of both gender, aged greater than or equal to 18 years; and lower than 70 years.
2. Patients diagnosed with RA for at least 6 months according to the criteria of the American College of Rheumatology (ACR) in 1987 for classification of AR.
3. Patients with a medical indication for therapy with rituximab, with prescription of this therapy for the first time and have not yet received the first dose.
4. DAS28 score greater than or equal to 3.2.
5. Use of adequate contraception, as judged from the attending physician.
6. Desire to participate voluntarily, the ability to understand the protocol, documented by signing the consent form (attached).
Exclusion Criteria:
1. overlapping rheumatic disease, autoimmune lymphoproliferative and neoplastic.
2. active infection, patients with the use of cytotoxic drugs, presence of positive serology for HCV, HBV and HIV, active or latent tuberculosis.
3. allergy or hypersensitivity to rituximab.
4. pregnant woman or performing breastfeeding.
5. participating in another clinical study with intervention.
6. with functional class IV defined based on the criteria of Steinbrocker functional classification for RA.
7. prior therapy with Rituximab.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01096069
Study Brief:
Protocol Section:
NCT01096069