Treatment for patients with eosinophilic asthma MedDRA version: 18.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
Conditions
Interventions
Product Name: Reslizumab
Product Code: CEP-38072
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Reslizumab
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent is obtained; informed consent from parents/guardians and assent from the patient must be obtained if the patient is under 18 years old, according to local Independent Ethics Committee [IEC] requirements. • The patient was enrolled in Study C38072/3085 and attended the Study C38072/3085 end of treatment visit or early termination visit as per protocol. In all cases, at least 28 days must have passed since the patient’s last dose of reslizumab in the previous study. • In the opinion of the Study C38072/3085 physician, the benefit for the patient from continued treatment with intravenous reslizumab outweighs any potential risk, and in whom no viable marketed alternatives exist for the patient. • All female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test (beta human chorionic gonadotropin [ß-HCG]) (urine). • Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 4 months after the last drug administration (approximately 5 reslizumab half lives). Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected). NOTE: Partner sterility alone is not acceptable for inclusion in the study. • The patient must be willing and able to comply with program restrictions and to remain at the clinic for the required duration during the treatment period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • The patient has had a clinically significant change in health status during Study C38072/3085 that would decrease the anticipated benefit, or increase the anticipated risk, of continued use of reslizumab. • The patient had a hypersensitivity reaction, excluding local injection-site reactions, related to reslizumab or other components of the infusate, during Study C38072/3085. • The patient is expected to be poorly compliant with drug administration, program procedures, or visits. • Female patients who are pregnant, nursing, or, if of childbearing potential, and not using a medically accepted, effective method of birth control (eg, barrier method with spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study. NOTE: Partner sterility alone is not considered an acceptable form of birth control. Patients should not be enrolled if they plan to become pregnant during the period of open-label treatment or within 4 months after the last infusion. • Patient is using a biologic or small molecule immunomodulatory medication (eg, methotrexate, cyclosporin, interferons, specific tumor necrosis factor inhibitors, anti-human interleukin-5 [anti-hIL-5] antibody, omalizumab [Xolair®, Genentech and Novartis] anti-immunoglobulin-E), or any investigational product, regardless of mechanism of action. Systemic corticosteroid for asthma or stable allergen immunotherapy is allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this open-label study is to obtain additional long-term safety data for reslizumab in patients with eosinophilic asthma who were enrolled in open-label extension Study C38072/3085. These data include adverse events, vital signs, and concomitant medications.;Secondary Objective: The secondary objective is to assess the maintenance of therapeutic effect during the study based on the incidence of asthma exacerbations.;Primary end point(s): Safety evaluations to be performed at every treatment visit include adverse event inquiry, vital signs measurement, concomitant medication use, brief physical examination, and urine pregnancy test. ;Timepoint(s) of evaluation of this end point: Safety evaluations to be performed at every treatment visit include adverse event inquiry, vital signs measurement, concomitant medication use, brief physical examination, and urine pregnancy test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are no pre-specified efficacy evaluations. Standard of care assessments of asthma control will be performed as per the investigator’s usual practice. However, the maintenance of reslizumab therapeutic effect will be assessed by determining the incidence of adverse events designated as a “clinical asthma exacerbation”. ; Timepoint(s) of evaluation of this end point: At each clinic visit, the patient will be questioned as to whether a worsening of asthma occurred since the last visit. A worsening of asthma will be recorded in the adverse event electronic case report form (eCRF) if it fulfills the adverse event definition in Section 7.1.1; the investigator will specifically designate the event in the Adverse Event eCRF as being a “clinical asthma exacerbation” if it meets 1 or more of the following criteria: 1) use of systemic corticosteroids (or at least a doubling of the maintenance dose of systemic corticosteroids) for 3 days or more, 2) an emergency department visit because of asthma that required systemic corticosteroids for 3 days or more, or 3) hospitalization because of asthma. | — |
Countries
France
Contacts
Public ContactProject Management
PPD
Outcome results
None listed