Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).

Key facts

Study ID

NCT01972568

Run by

EMD Serono

People needed

306

Starts

2013-12-01

Expected to finish

2016-09-01

Last updated by the study team

2018-01-02

Who can join

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

You may qualify if…

• Eligible male and female subjects, aged 18 years or older
• Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening visit
• At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed >= 6 months prior to the screening visit)
• Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies
• Other protocol defined inclusion criteria could apply

You may not qualify if…

• Subjects have demyelinating disorder
• Severe central nervous system SLE
• Use of cyclophosphamide within 3 months of the screening visit
• Urine protein:creatinine ratio (UPCr) >= 2 milligram per milligram (mg/mg) per day
• Other protocol defined exclusion criteria could apply

Where it is running

• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• University of Alabama at Birmingham - (UAB) — Birmingham, Alabama, United States
• Southern California Permanente Medical Group — Anaheim, California, United States
• Wallace Rheumatic Study Center — Los Angeles, California, United States
• East Bay Rheumatology Medical Group, Inc. — San Leandro, California, United States
• Clinical Research of West Florida - Corporate — Dunedin, Florida, United States
• Center for Rheumatology, Immunology & Arthritis — Fort Lauderdale, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States
• Goldpoint Clinical Research, LLC — Indianapolis, Indiana, United States
• AA MRC LLC Ahmed Arif Medical Research Center — Grand Blanc, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• North MS Medical Clinics, Inc. — Tupelo, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• The Feinstein Institute for Medical Research — Manhasset, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Box Arthritis & Rheumatology of the Carolinas PLLC — Charlotte, North Carolina, United States
• MetroHealth System — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• STAT Research, Inc. — Dayton, Ohio, United States
• Arthritis & Rheumatology Center of Oklahoma — Oklahoma City, Oklahoma, United States
• OMRF — Oklahoma City, Oklahoma, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Pinnacle Research Group LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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