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
This study is ongoing, but not recruiting participants.
Sponsor:
Cephalon
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01290887
First received: February 4, 2011
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Eosinophilic Asthma |
Drug: Reslizumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An 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 Who Completed a Prior Cephalon-Sponsored Study in Eosinophilic Asthma |
Resource links provided by NLM:
Genetics Home Reference related topics:
PDGFRA-associated chronic eosinophilic leukemia
PDGFRB-associated chronic eosinophilic leukemia
MedlinePlus related topics:
Asthma
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- Evaluate the Long-Term Safety of Reslizumab administration [ Time Frame: up to 104 weeks of treatment and a 90-day follow-up evaluation ] [ Designated as safety issue: Yes ]- as assessed by adverse events, physical examination findings, vital sign measurements, concomitant medication usage, clinical laboratory test results, and measurement of antidrug antibodies
Secondary Outcome Measures:
- Lung function as measured by Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Lung function as measured by percent predicted Forced Expiratory Volume in 1 second (%FEV1) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Lung function as measured by Forced Vital Capacity (FVC) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Lung function as measured by Forced Expiratory Flow at 25% to 75% FVC (FEF25-75%) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Short-acting Beta-agonist usage [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Asthma symptoms as measured by the Asthma Symptom Utility Index (ASUI) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Asthma control as measured by the Asthma Control Questionnaire (ACQ) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: 116 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 740 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Reslizumab |
Drug: Reslizumab
Reslizumab (3.0 mg/kg) will be administered intravenously by infusion every 28 days (±7 days), for approximately 24 months
|
Eligibility| Ages Eligible for Study: | 12 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in India and Argentina; patients 66 through 75 years of age are excluded from participating in India.
- Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.
- 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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290887
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| United States, Arizona | |
| Teva Investigational Site 58 | |
| Scottsdale, Arizona, United States | |
| United States, California | |
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| Zaporizhzhia, Ukraine | |
Sponsors and Collaborators
Cephalon
Investigators
| Study Director: | Sponsor's Medical Expert, Senior Director - Worldwide Clinical Research | Cephalon |
More Information
No publications provided
| Responsible Party: | Teva Pharmaceutical Industries ( Cephalon ) |
| ClinicalTrials.gov Identifier: | NCT01290887 History of Changes |
| Other Study ID Numbers: | C38072/3085 |
| Study First Received: | February 4, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Food and Drug Administration Argentina: Ministry of Health Australia: Department of Health and Ageing Therapeutic Goods Administration Belarus: Ministry of Health Belgium: Federal Agency for Medicinal Products and Health Products Brazil: Ministry of Health Canada: Health Canada Chile: Ministry of Health Colombia: National Institutes of Health Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Ministry of Health Greece: Ministry of Health and Welfare Hungary: National Institute of Pharmacy India: Ministry of Health Israel: Israeli Health Ministry Pharmaceutical Administration Malaysia: Ministry of Health Mexico: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) New Zealand: Ministry of Health Norway: Norwegian Medicines Agency Peru: Ministry of Health Philippines: Bureau of Food and Drugs Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Russia: Pharmacological Committee, Ministry of Health Slovakia: State Institute for Drug Control South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) Sweden: Medical Products Agency Thailand: Food and Drug Administration Ukraine: State Pharmacological Center - Ministry of Health |
Additional relevant MeSH terms:
|
Asthma Pulmonary Eosinophilia Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Hypereosinophilic Syndrome Eosinophilia Leukocyte Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013