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
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
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 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.