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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT00320450
Eligibility Criteria:
Inclusion Criteria:
* Females cannot be pregnant or lactating.
* Must use defined contraceptive methods if of child-bearing potential.
* BMI range: 18.5-35.0 kg/m2.
* Diagnosis of RA (rheumatoid arthritis) according to revised 1987 American College of Rheumatology (ACR) criteria.
* If other RA-medication is used: Disease-Modifying Anti-Rheumatic Drug (DMARDS) must be stable for at least 8 weeks before first trial visit.
* If other oral anti-RA therapies are used, these must have been stable at least 4 weeks before first trial visit.
* If Methotrexate medication is used as RA-therapy, Folate supplement must be taken with stable red cell folate levels.
* Must give informed consent.
* Must abstain from alcohol during the trial participation.
Exclusion Criteria:
* Non-responder on biological RA treatment.
* Has a positive alcohol screen.
* Any history of liver disease.
* Positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening.
* Have any significant disease that places the subject at unacceptable risk as a participant in this trial.
* Acute infection.
* History of active tuberculosis.
* History of repeated or chronic infection.
* History of malignancy.
* History of HIV or other immunosuppressive diseases.
* Participated in a clinical trial within the last 3 months for non-biological therapies and 6 months for biological therapies.
* Uncontrolled diabetes or psoriasis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00320450
Study Brief:
Protocol Section:
NCT00320450