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Therapeutic Areas: Immunology | Musculoskeletal | Rheumatology | Nephrology
Disease Category: Systemic Lupus Erythematosus
Location: United States, NY
Clinical Trial Details
Research Study Summary
Systemic Lupus Erythematosus (SLE) - Adults
People with systemic lupus erythematosus are asked to participate in a research study being conducted by The Feinstein Institute for Medical Research.
Patient Inclusion Criteria
You may be eligible to participate in this study if you:
- Are at least 18 years of age or older
- Have been diagnosed with SLE
- Have active lupus nephritis
Patient Exclusion Criteria
You may not participate in this study if you:
- Have currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia.
- Have severe renal impairment
- Have a history of severe allergic or anaphylactic reactions to humanized, chimeric or murine monoclonal antibodies or i.v. immunoglobulin
- Have severe chronic pulmonary disease
- Have significant or uncontrolled concomitant diseases in any organ system not related to SLE (e.g. renal thrombosis, atherosclerotic cardiovascular disease, diabetes mellitus, accelerated hypertension, poorly controlled COPD or asthma
- Have a concomitant condition (e.g. asthma, Crohn's disease, etc), which has required treatment with systemic corticosteroid (excluding topical or inhaled) at any time in the 52 weeks prior to screening.
- Have HIV or chronic active Hepatitis B or chronic active Hepatitis C infection
- Have a known active infection of any kind (but excluding fungal infection of nail beds or oral thrush which has resolved before Day 1) within 30 days prior. In addition, any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives in the 30 days prior to Day 1 or oral anti-infectives in the 14 days prior to Day 1
- Have history of cancer, including solid tumors, hematological malignancies and carcinoma in situ (except basal cell carcinoma of the skin that has been excised and cured)
- Have history of alcohol or drug abuse in the 52 weeks prior to screening
- Have had major surgery in the 4 weeks prior to screening excluding diagnostic surgery
- Have had previous treatment with CAMPATH-1H, a BAFF directed treatment (e.g. anti-BLyS), a B-cell targeted therapy or have received any live vaccine in the 6 weeks prior to Day 1
- Are pregnant, breastfeeding, or intend to become pregnant during the study
- Have participated in another research study within the last 30 days
To Learn more
Both Male and Female
Date Last Changed:
July 25, 2013
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