Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma



Status:Terminated
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - 75
Updated:4/21/2016
Start Date:June 2011
End Date:January 2015

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An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study in Eosinophilic Asthma

The primary objective of the study is to evaluate the long-term safety of reslizumab at a
dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult
patients with eosinophilic asthma as assessed by adverse events, physical examination
findings, vital sign measurements, and concomitant medication usage throughout the study
(every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

Study patients were deemed eligible based on activities from the preceding Teva sponsored
double blind study of reslizumab in eosinophilic asthma. Specifically, as per inclusion
criterion c, patients must have either completed treatment in a previous Teva-sponsored
study or have received at least 2 doses of study drug treatment in a pulmonary function
study.

Eligible patients could enroll in this study only after completion of the end of treatment
visit in a Teva sponsored, randomized, placebo controlled, double blind study of reslizumab
in eosinophilic asthma, which served as the screening/baseline visit for participation in
this open label extension study. The use of systemic corticosteroids for asthma in any of
the previous Teva sponsored double blind studies of reslizumab did not exclude patients from
this study. The previous Teva studies were C38072/3081 (NCT01270464), C38072/3082
(NCT01287039), and C38072/3083 (NCT01285323).

Inclusion Criteria:

- Written informed consent is obtained.

- Patient must have completed treatment in a previous Cephalon-sponsored double-blind
asthma exacerbation study or received at least 2 doses of study drug treatment in a
pulmonary function study.

- The patient must be willing and able to comply with study restrictions and to remain
at the clinic for the required duration during the study period, and willing to
return to the clinic for the follow-up evaluation as specified in this protocol.

- other criteria may apply; please contact the investigator for more information.

Exclusion Criteria:

- The patient has a clinically meaningful comorbidity that would interfere with the
study schedule or procedures, or compromise the patient's safety.

- The patient has another confounding underlying lung disorder (eg, chronic obstructive
pulmonary disease, pulmonary fibrosis, or lung cancer).

- The patient is a current smoker.

- The patient is expected to be poorly compliant with study drug administration, study
procedures, or visits.

- The patient has any aggravating factors that are inadequately controlled (e.g.,
gastroesophageal reflux disease [GERD]).

- Female patients who are pregnant, or nursing, or, if of childbearing potential and
not using a medically accepted, effective method of birth control (eg, spermicide,
abstinence, intrauterine device [IUD], or steroidal contraceptive [oral, transdermal,
implanted, and injected] in conjunction with a barrier method) are excluded from this
study.

- The patient has a current infection or disease that may preclude assessment of
asthma.

- other criteria may apply; please contact the investigator for more information.
We found this trial at
43
sites
Lexington, Kentucky
725
mi
from
Lexington, KY
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Altoona, Pennsylvania
1055
mi
from
Altoona, PA
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Anaheim, California
1155
mi
from
Anaheim, CA
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1575
mi
from
Bangor, ME
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552
mi
from
Boerne, TX
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Boys Town, Nebraska
258
mi
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Boys Town, NE
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Charleston, South Carolina
1063
mi
from
Charleston, SC
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Cincinnati, Ohio
726
mi
from
Cincinnati, OH
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Ciudad Autonoma de Buenos Aire,
?
mi
from
Ciudad Autonoma de Buenos Aire,
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Clearwater, Florida
1100
mi
from
Clearwater, FL
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Colorado Springs, Colorado
386
mi
from
Colorado Springs, CO
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348
mi
from
Dallas, TX
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409
mi
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Denver, CO
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642
mi
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El Paso, TX
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Fort Worth, Texas
346
mi
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Fort Worth, TX
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Fountain Valley, California
1160
mi
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Fountain Valley, CA
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Fresno, California
1207
mi
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Fresno, CA
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1103
mi
from
Largo, FL
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Lawrenceville, Georgia
816
mi
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Lawrenceville, GA
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811
mi
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Lilburn, GA
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Lincoln, Rhode Island
1422
mi
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Lincoln, RI
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Long Beach, California
1172
mi
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Long Beach, CA
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Los Angeles, California
1168
mi
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Los Angeles, CA
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Madison, Wisconsin
575
mi
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Madison, WI
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Medford, Oregon 97504
1355
mi
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Medford, OR
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1321
mi
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Miami, FL
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Nashville, Tennessee
619
mi
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Nashville, TN
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Oklahoma City, Oklahoma
158
mi
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Oklahoma City, OK
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262
mi
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Omaha, NE
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Orange, California
1153
mi
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Orange, CA
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1141
mi
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Orlando, FL
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Providence, Rhode Island
1424
mi
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Providence, RI
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San Antonio, Texas
576
mi
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San Antonio, TX
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Savannah, Georgia 31406
1026
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Savannah, GA
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Scottsdale, Arizona
843
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Scottsdale, AZ
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St. Louis, Missouri
418
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St. Louis, MO
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Summit, New Jersey
1268
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Summit, NJ
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Tallahassee, Florida
923
mi
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Tallahassee, FL
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Trinity, Florida
1096
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Trinity, FL
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1127
mi
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Valrico, FL
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Walnut Creek, California
1319
mi
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Walnut Creek, CA
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Waterbury, Connecticut
1338
mi
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Waterbury, CT
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Winston-Salem, North Carolina 27103
973
mi
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Winston-Salem, NC
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