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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT00049751
Eligibility Criteria:
Inclusion:
* Subjects must meet ACR criteria for diagnosis of RA for at least 3 months, must meet ACR Functional Class I, II or III (1992 criteria) and must have a confirmed diagnosis of active moderate to severe rheumatoid arthritis as defined by 6 or more swollen joints and 9 or more tender joints;
* must also have DAS of 3.2 or greater at study entry,
* normal laboratory parameters and ESR \>20,
* satisfactory response or intolerance to one or more prior DMARDs and
* be willing and able to give informed consent.
Exclusion:
* Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia,
* history of acute inflammatory joint disease other than RA,
* prior treatment with cyclophosphamide or chlorambucil,
* prior treatment with intravenous immunoglobulin within 70 days,
* history of malignant lymphoma,
* history of uncontrolled diabetes,
* unstable ischemic heart disease,
* active inflammatory bowel disease,
* active peptic ulcer disease or stroke,
* positive HIV status,
* positive serology for Hepatitis B or C,
* no previous history of tuberculosis or listeria infection,
* no previous history of cancer other than successfully treated skin cancer;
* women can not be pregnant or be breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00049751
Study Brief:
Protocol Section:
NCT00049751