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

Use our guide to learn which trials are right for you!

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
Fountain Valley, California
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Altoona, Pennsylvania
?
mi
from
Altoona, PA
Click here to add this to my saved trials
Anaheim, California
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Bangor, ME
Click here to add this to my saved trials
?
mi
from
Boerne, TX
Click here to add this to my saved trials
Boys Town, Nebraska
?
mi
from
Boys Town, NE
Click here to add this to my saved trials
Charleston, South Carolina
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Cincinnati, Ohio
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Ciudad Autonoma de Buenos Aire,
?
mi
from
Ciudad Autonoma de Buenos Aire,
Click here to add this to my saved trials
Clearwater, Florida
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Colorado Springs, Colorado
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Fort Worth, Texas
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fresno, California
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Largo, FL
Click here to add this to my saved trials
Lawrenceville, Georgia
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
Lexington, Kentucky
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Lilburn, GA
Click here to add this to my saved trials
Lincoln, Rhode Island
?
mi
from
Lincoln, RI
Click here to add this to my saved trials
Long Beach, California
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Madison, Wisconsin
?
mi
from
Madison, WI
Click here to add this to my saved trials
Medford, Oregon 97504
?
mi
from
Medford, OR
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange, California
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Providence, Rhode Island
?
mi
from
Providence, RI
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Savannah, Georgia 31406
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Scottsdale, Arizona
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
St. Louis, Missouri
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Summit, New Jersey
?
mi
from
Summit, NJ
Click here to add this to my saved trials
Tallahassee, Florida
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Trinity, Florida
?
mi
from
Trinity, FL
Click here to add this to my saved trials
?
mi
from
Valrico, FL
Click here to add this to my saved trials
Walnut Creek, California
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
Waterbury, Connecticut
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials