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
Saint Louis, Missouri 63110
398
mi
from 43215
Saint Louis, MO
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Anniston, Alabama 36207
461
mi
from 43215
Anniston, AL
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Austin, Texas 78731
1062
mi
from 43215
Austin, TX
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8750 Wilshire Boulevard
Beverly Hills, California 90211
1978
mi
from 43215
Beverly Hills, CA
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Birmingham, Alabama 35294
493
mi
from 43215
Birmingham, AL
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Charleston, South Carolina 29425
Phone: 843-792-1991
524
mi
from 43215
Charleston, SC
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Charlotte, North Carolina 28210
354
mi
from 43215
Charlotte, NC
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Clearwater, Florida 33765
Phone: 727-466-0078
829
mi
from 43215
Clearwater, FL
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Cleveland, Ohio 44109
Phone: 216-778-5219
123
mi
from 43215
Cleveland, OH
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9961 Sierra Avenue
Fontana, California 92335
1928
mi
from 43215
Fontana, CA
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Grand Blanc, Michigan 48439
Phone: 810-237-1125
207
mi
from 43215
Grand Blanc, MI
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494
mi
from 43215
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
480
mi
from 43215
New York, NY
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Newark, New Jersey 07103
467
mi
from 43215
Newark, NJ
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Oklahoma City, Oklahoma 73103
849
mi
from 43215
Oklahoma City, OK
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Oklahoma City, Oklahoma 73104
849
mi
from 43215
Oklahoma City, OK
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Rochester, Minnesota 55905
559
mi
from 43215
Rochester, MN
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Rosario, Santa Fe
5236
mi
from 43215
Rosario,
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6400 Clayton Road
Saint Louis, Missouri 63117
400
mi
from 43215
Saint Louis, MO
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San Leandro, California 94578
Phone: 510-357-1303
2093
mi
from 43215
San Leandro, CA
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5115 North Armenia Avenue
Tampa, Florida 33603
Phone: 813-870-1292
827
mi
from 43215
Tampa, FL
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Tampa, Florida 33613
821
mi
from 43215
Tampa, FL
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980
mi
from 43215
Waco, TX
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Wyomissing, Pennsylvania 19610
373
mi
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Wyomissing, PA
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