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:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT01753193
Eligibility Criteria:
Inclusion Criteria:
* Must be willing to use 2 methods of effective contraception
* Must have venous access
* Must be willing to forego participation in other clinical trials for SLE.
Exclusion Criteria:
* Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
* Major surgery within 8 weeks before signing informed consent form (ICF)
* Elective major surgery planned during the study period
* Concomitant Medications within the last 12 weeks: Azathioprine \> 200 mg/day, Mycophenolate mofetil/mycophenolic acid \> 2.0 g/day, oral, subcutaneous, or intramuscular methotrexate \> 25 mg/week
* A live or attenuated vaccine within 4 weeks of signing the ICF
* Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
68 Years
Study:
NCT01753193
Study Brief:
Protocol Section:
NCT01753193