Male and female subjects with multiple sclerosis who have completed natalizumab studies C-1801, C-1802, or C-1803
Conditions
Interventions
Product Name: natalizumab
Product Code: AN100226
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: natalizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
Biogen Idec Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Must give written informed concent. Must be an MS subject who has completed studies C-1801, C-1802, or C-1803 C-1801 subjects must have completed all protocol-required evaluations (through the end of the study), and either remained on study drug for the entire study period or discontinued study drug after experiencing protocol-defined disease progression and chose treatment options specified in the protocol. C-1802 subjects must have completed all protocol-required evaluations (through the end of the study), and either remained on study drug and/or AVONEX for the entire study period or discontinued study drug after experiencing protocol-defined disease progression and chose treatment options specified in the protocol. C-1803 subjects must have completed all protocol-required evaluations (through the end of the study) and remained on the study drug for the entire study 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of, or available abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermantologic, psychiatric (including major depression), renal, and/or other major disease, that would preclude the administration of natalizumab for 24 months. History of malignancy. Histroy of severe allergic or anaphylactic reactions or known drug hypersensitivity. A significant change (as determined by the Investigator) in the subject's medical history from their previous natalizumab study. A clinically significant infectious illness within 30 days prior to study entry visit in study C-1808. C-1802 subjects who have discontinued both study drug and AVONEX. Any subjects who have discontinued study drug in study C-1801, C-1802, or C-1803 because of an AE or due to reasons other than significant disease progression. Female subjects who are not post menopausal for at least 1 year, surgically sterile or willing to practice effective contraception during the study. Women who are breast feeding, pregnant or planning to become pregnant while on the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed studies C-1801, C-1802, or C-1803.;Secondary Objective: To determine the durability of the efficacy response of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed studies C-1801, C-1802, or C-1803.;Primary end point(s): The primary objective of the study is to determine the safety and immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg IV to subjects with multiple sclerosis who have completed natalizumab studies C-1801, C-1802, or C-1803. The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed. | — |
Countries
Sweden
Outcome results
None listed