Clareo Health | PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Anthera Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of SLE by American College of Rheumatology guidelines.
On stable SLE treatment
Active SLE disease
Serologically active
18 years of age or older
Receiving stable doses of prednisone between 7.5 mg and 40 mg per day
You may not be if
Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
Liver disease.
Anemia, neutropenia, or thrombocytopenia.
Malignancy within past 5 years
Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
History of active tuberculosis or a history of tuberculosis infection.
Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
Prior administration of any B cell depleting therapy in the past 18 months.
