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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT00137969
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of systemic lupus erythematosus (SLE).
* Active disease at screening.
* Stable use of one immunosuppressive drug.
* Use of an antimalarial drug.
* For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation.
Exclusion Criteria:
* Unstable patients with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
* Active moderate to severe glomerulonephritis.
* Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE.
* Lack of peripheral venous access.
* Pregnant women or nursing (breast feeding) mothers.
* History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
* Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude subject participation.
* Concomitant conditions that require oral or systemic corticosteroid use.
* Known human immunodeficiency virus (HIV) infection.
* Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics.
* History of deep space infection.
* History of serious recurrent or chronic infection.
* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
* Active alcohol or drug abuse, or history of alcohol or drug abuse.
* Major surgery.
* Previous treatment with CAMPATH-1H antibody.
* Previous treatment with any B cell-targeted therapy.
* Treatment with any investigational agent within 28 days of screening (Day -7) or 5 half-lives of the investigational drug (whichever is longer).
* Receipt of a live vaccine within 28 days prior to screening.
* Intolerance or contraindication to oral or IV corticosteroids.
* Use of a new immunosuppressive drug prior to screening or change in dose of ongoing immunosuppressive drug prior to screening.
* Prednisone dose of ≥ 1 mg/kg/day prior to screening.
* Treatment with cyclophosphamide or a calcineurin inhibitor.
* Treatment with a second immunosuppressive or immunomodulatory drug.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x the upper limit of normal.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
75 Years
Study:
NCT00137969
Study Brief:
Protocol Section:
NCT00137969