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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00089804
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Systemic Lupus Erythematosus (SLE)
* Active SLE renal disease within past 4 years.
* Males or females between 12 and 70 years old.
* Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.
* Ability to have weekly intravenous (IV) administration of study treatment.
Exclusion Criteria:
* Active SLE renal disease within past 3 months prior to entering study.
* Use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.
* Use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceeds 10 mg/week, leflunomide that exceeds 10 mg/day within 2 months prior to entering study.
* Use of rituximab within 6 months prior to entering study.
* Current abuse of drugs or alcohol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
70 Years
Study:
NCT00089804
Study Brief:
Protocol Section:
NCT00089804