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



Status:Terminated
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:July 29, 2014
End Date:February 9, 2018

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A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
24
sites
Anniston, Alabama 36207
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Austin, Texas 78731
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8750 Wilshire Boulevard
Beverly Hills, California 90211
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Birmingham, Alabama 35294
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Birmingham, AL
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Charleston, South Carolina 29425
Phone: 843-792-1991
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Charlotte, North Carolina 28210
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Charlotte, NC
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Clearwater, Florida 33765
Phone: 727-466-0078
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Clearwater, FL
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Cleveland, Ohio 44109
Phone: 216-778-5219
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Cleveland, OH
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9961 Sierra Avenue
Fontana, California 92335
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Fontana, CA
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Grand Blanc, Michigan 48439
Phone: 810-237-1125
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Grand Blanc, MI
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Manhasset, NY
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535 E 70th St
New York, New York 10021
(212) 606-1000
Phone: 212-774-2291
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, NY
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Newark, New Jersey 07103
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Newark, NJ
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Oklahoma City, Oklahoma 73103
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73104
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Rochester, Minnesota 55905
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Rochester, MN
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Rosario, Santa Fe
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Rosario,
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Saint Louis, Missouri 63110
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Saint Louis, MO
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6400 Clayton Road
Saint Louis, Missouri 63117
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Saint Louis, MO
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San Leandro, California 94578
Phone: 510-357-1303
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San Leandro, CA
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5115 North Armenia Avenue
Tampa, Florida 33603
Phone: 813-870-1292
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Tampa, FL
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Tampa, Florida 33613
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Tampa, FL
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Waco, TX
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Wyomissing, Pennsylvania 19610
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Wyomissing, PA
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