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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT00203151
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to give written informed consent
2. Between the ages of 18 and 65 years (inclusive)
3. Fulfilled at least 4 ACR classification criteria
4. SLE patients with moderate, active disease
5. Subjects on stable dose of SLE medications for at least 4 weeks before randomization.
6. Women of child-bearing potential must practice a medically acceptable method of contraception..
7. Must understand the requirements of the study and agree to comply with the study protocol.
Exclusion Criteria:
1. Any condition which the investigator feels may interfere with participation in the study.
2. Subjects having a history of chronic infection
3. Subjects with a history of immunodeficiency syndrome or malignancy,
4. Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization,
5. Subjects treated with any cytotoxic agents in the 3 months prior to randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00203151
Study Brief:
Protocol Section:
NCT00203151