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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT00594932
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of SLE by the 1995 modification of revised ACR criteria (includes antiphospholipid antibodies)
2. BILAG A arthritis or BILAG B arthritis with at least 6 tender and 4 swollen joints at screening and baseline
3. Stable prednisone dose at 20 mg of less for one month at baseline.
4. If on antimalarials must be stable for at least one month at baseline
5. If on NSAIDS must be on a stable regimen for at least one month but can be prn dosing
6. Must be willing to withdraw from azathioprine or MTX at the time of screening.
7. Between ages 14 and 70
8. Women of childbearing potential must have a negative pregnancy test at screening and at each month during the study.
9. All participants (male and female) must, if fertile, agree to practice contraception during the entire course of the study. This may include barrier, oral contraceptives, depo-provera, intrauterine device and/or abstinence.
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Exclusion Criteria:
1. Inability to understand informed consent
2. Drug or alcohol abuse within the past six months
3. In the opinion of the investigator, it is not likely the patient can comply with the protocol for any reason, or participation in the protocol is not in the patient's best interest.
4. Unstable medical condition that, in the opinion of the investigator would contraindicate study participation
5. History of malignancy (except for basal cell carcinoma at any time and/or cervical cancer or squamous cell cancer at least five years previous to screening).
6. Use of cyclosporine, leflunomide, cyclophosphamide or ay biologic agent within three months prior to screening.
7. Participation in any clinical study of an investigational agent within three months of screening -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
70 Years
Study:
NCT00594932
Study Brief:
Protocol Section:
NCT00594932