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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT00000435
Eligibility Criteria:
Inclusion Criteria:
* Active rheumatoid arthritis as defined by the revised American College of Rheumatology (ACR) 1987 criteria. Evidence of active disease will be based on at least six swollen or nine tender joints.
* Diagnosis of rheumatoid arthritis of less than 5 years
* Reactivity to dnaJ
* Agree to use acceptable methods of contraception
* Able to understand and sign informed consent
Exclusion Criteria:
* Patients taking more 7.5 mg of prednisone or disease modifying agents other than hydrochloroquine or sulfasalazine (i.e., gold, penicillamine, azathioprine, cyclophosphamide, methotrexate, cyclosporine, or anti-TNF agents)
* Serum creatinine greater than 1.5 mg/dl
* SGOT less than SGPT
* Alkaline phosphatase greater than 2 times age/sex adjusted normal values
* Hematocrit of less than 30
* Platelets less than 130,000
* History of lymphoma
* Any active malignancy or cancer requiring treatment in the last 5 years, except for nonmelanoma skin cancers and carcinoma of the cervix in situ
* Medical or psychiatric condition or active serious infection
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00000435
Study Brief:
Protocol Section:
NCT00000435