PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease

Key facts

Study ID

NCT01162681

Run by

Anthera Pharmaceuticals

People needed

547

Starts

2010-07-01

Expected to finish

2012-04-01

Last updated by the study team

2014-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.
• Pregnant or nursing
• History of congenital immunodeficiency

Where it is running

• Investigator Site 113 — Long Beach, California, United States
• Investigator Site 108 — Los Angeles, California, United States
• Investigator Site 110 — Upland, California, United States
• Investigator Site 105 — Orlando, Florida, United States
• Investigator Site 102 — Tampa, Florida, United States
• Investigator Site 117 — Baltimore, Maryland, United States
• Investigator Site 104 — Lansing, Michigan, United States
• Investigator Site 106 — Lake Success, New York, United States
• Investigator Site 114 — Smithtown, New York, United States
• Investigator Site 101 — Greenville, North Carolina, United States
• Investigator Site 112 — Oklahoma City, Oklahoma, United States
• Investigator Site 111 — Tulsa, Oklahoma, United States
• Investigator Site 115 — Houston, Texas, United States
• Investigator Site 404 — Caba, Buenos Aires, Argentina
• Investigator Site 402 — Caba, Buenos Aires, Argentina
• Investigator Site 408 — San Juan, San Juan Province, Argentina
• Investigator Site 403 — Rosario, Santa Fe Province, Argentina
• Investigator Site 406 — San Miguel de Tucumán, Tucumán Province, Argentina
• Investigator Site 407 — Buenos Aires, Argentina
• Investigator Site 401 — Buenos Aires, Argentina
• Investigator Site 504 — Salvador, Estado de Bahia, Brazil
• Investigator Site 509 — Goiás, Goiania, Brazil
• Investigator Site 507 — Goiânia, Goiás, Brazil
• Investigator Site 506 — Juiz de Fora, Minas Gerais, Brazil
• Investigator Site 103 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.