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
Oklahoma City, Oklahoma
1523
mi
from 98109
Oklahoma City, OK
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Altoona, Pennsylvania
2205
mi
from 98109
Altoona, PA
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Anaheim, California
980
mi
from 98109
Anaheim, CA
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2517
mi
from 98109
Bangor, ME
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1758
mi
from 98109
Boerne, TX
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Boys Town, Nebraska
1357
mi
from 98109
Boys Town, NE
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Charleston, South Carolina
2423
mi
from 98109
Charleston, SC
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Cincinnati, Ohio
1967
mi
from 98109
Cincinnati, OH
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Ciudad Autonoma de Buenos Aire,
?
mi
from 98109
Ciudad Autonoma de Buenos Aire,
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Clearwater, Florida
2511
mi
from 98109
Clearwater, FL
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Colorado Springs, Colorado
1067
mi
from 98109
Colorado Springs, CO
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1681
mi
from 98109
Dallas, TX
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1020
mi
from 98109
Denver, CO
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1377
mi
from 98109
El Paso, TX
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Fort Worth, Texas
1660
mi
from 98109
Fort Worth, TX
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Fountain Valley, California
988
mi
from 98109
Fountain Valley, CA
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Fresno, California
763
mi
from 98109
Fresno, CA
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2514
mi
from 98109
Largo, FL
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Lawrenceville, Georgia
2188
mi
from 98109
Lawrenceville, GA
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Lexington, Kentucky
2005
mi
from 98109
Lexington, KY
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2184
mi
from 98109
Lilburn, GA
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Lincoln, Rhode Island
2481
mi
from 98109
Lincoln, RI
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Long Beach, California
982
mi
from 98109
Long Beach, CA
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Los Angeles, California
962
mi
from 98109
Los Angeles, CA
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Madison, Wisconsin
1617
mi
from 98109
Madison, WI
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Medford, Oregon 97504
366
mi
from 98109
Medford, OR
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2732
mi
from 98109
Miami, FL
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Nashville, Tennessee
1971
mi
from 98109
Nashville, TN
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1366
mi
from 98109
Omaha, NE
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Orange, California
984
mi
from 98109
Orange, CA
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2547
mi
from 98109
Orlando, FL
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Providence, Rhode Island
2486
mi
from 98109
Providence, RI
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San Antonio, Texas
1787
mi
from 98109
San Antonio, TX
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Savannah, Georgia 31406
2404
mi
from 98109
Savannah, GA
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Scottsdale, Arizona
1117
mi
from 98109
Scottsdale, AZ
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St. Louis, Missouri
1720
mi
from 98109
St. Louis, MO
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Summit, New Jersey
2384
mi
from 98109
Summit, NJ
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Tallahassee, Florida
2329
mi
from 98109
Tallahassee, FL
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Trinity, Florida
2506
mi
from 98109
Trinity, FL
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2536
mi
from 98109
Valrico, FL
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Walnut Creek, California
672
mi
from 98109
Walnut Creek, CA
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Waterbury, Connecticut
2419
mi
from 98109
Waterbury, CT
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Winston-Salem, North Carolina 27103
2273
mi
from 98109
Winston-Salem, NC
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