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 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT01593332
Eligibility Criteria:
Inclusion Criteria:
* 1987 ACR criteria for classification of RA
* Positive for rheumatoid factor(RF)
* Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 \> 3/2
* Patients with active, resistant RA who didn't receive anti TNF agents.
Exclusion Criteria:
* Patient with hypogammaglobulinemia
* Patient with congestive heart failure (classIV)
* Active current bacterial,viral,fungal,myocardial or other infections
* Chronic hepatitis B or hepatitis C carriers
* History of severe allergic reaction to human,humanized or murine monoclonal antibodies
* History of malignancies
* Pregnant women or lactating mothers 8) Patients with Chronic renal failure and hepatic disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT01593332
Study Brief:
Protocol Section:
NCT01593332