A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321

Completed · Phase 2

Conditions studied: Systemic Lupus Erythematosus

In brief

The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.

Key facts

Study ID

NCT01305746

Run by

Anthera Pharmaceuticals

People needed

382

Starts

2011-04-01

Expected to finish

2013-10-01

Last updated by the study team

2014-02-13

Who can join

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

You may qualify if…

• Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010

You may not qualify if…

• Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures
• Pregnant or nursing
• Any prior administration of a B-cell modulating therapy other than A-623
• Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods

Where it is running

• Investigator Site 113 — Long Beach, 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 407 — Caba, Buenos Aires, Argentina
• Investigator Site 401 — 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 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 511 — Rio de Janeiro, Rio de Janeiro, Brazil
• Investigator Site 103 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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