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 |
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.
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).
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
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