Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.

Key facts

Study ID

NCT02070978

Run by

EMD Serono

People needed

253

Starts

2014-07-29

Expected to finish

2018-02-09

Last updated by the study team

2019-03-21

Who can join

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

You may qualify if…

• Participants who had completed the 24-week treatment period of study EMR-700461-023 (ADDRESS II core trial)
• Women of childbearing potential who had a negative pregnancy test
• Other protocol defined inclusion criteria were applied

You may not qualify if…

• Active neurological symptoms of SLE that were deemed severe or progressive
• Diagnosis of any demyelinating disease, such as, but not restricted to, multiple sclerosis (MS) or optic neuritis
• Pregnancy
• Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection that in the investigator's opinion makes the participants unsuitable to continued participation in the study
• Other protocol defined exclusion criteria were applied

Where it is running

• University of Alabama at Birmingham - (UAB) — Birmingham, Alabama, United States
• Wallace Rheumatic Study Center — Beverly Hills, California, United States
• Southern California Permenent Medical Group — Fontana, California, United States
• East Bay Rheumatology Medical Group, Inc. — San Leandro, California, United States
• Clinical Research of West Florida - Corporate — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States
• McIlwain Medical Group, PA — Tampa, Florida, United States
• AA MRC LLC Ahmed Arif Medical Research Center — Grand Blanc, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Clayton Medical Associates, P.C. — 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
• DJL Clinical Research, PLLC — Charlotte, North Carolina, United States
• MetroHealth System — Cleveland, Ohio, United States
• Arthritis & Rheumatology Center of Oklahoma — Oklahoma City, Oklahoma, United States
• OMRF — Oklahoma City, Oklahoma, United States
• Clinical Research Center of Reading LLC — Wyomissing, Pennsylvania, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• Austin Regional Clinic, P.A. — Austin, Texas, United States
• Little River Arthritis & Osteoporosis Clinic — Waco, Texas, United States
• Instituto CAICI — Rosario, Santa Fe Province, Argentina
• Centro Medico Privado de Reumatologia — San Miguel de Tucumán, Tucumán Province, Argentina
• Pinnacle Research Group LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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