Relapsing Multiple Sclerosis MedDRA version: 17.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta 1a
Current Sponsor code: BIIB017
Other descriptive nam
Sponsors
Biogen Idec Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. 2. Subjects who participated in Study 105MS301, who completed the study treatment and visit schedule through Week 96. 3. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. 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 1495 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301. 2. Subjects with any significant change in medical history, including laboratory tests, or a current clinically significant condition that in the opinion of the Investigator would have excluded the subject from participation in Study 105MS301. The Investigator must re-review the subject’s medical fitness for participation and consider any factors that would preclude treatment including: • Presence of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study. • Presence of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured). • Clinically significant laboratory abnormalities (hematology and blood chemistry) on the most recently available test of Study 105MS301, as determined by the Investigator. Laboratory findings mandating discontinuation of study treatment as defined in protocol 105MS301 are exclusionary. 3. Female subjects who are currently pregnant (as reflected by a positive pregnancy test at the Week 96 Visit of Study 105MS301/Baseline Visit), who are currently breastfeeding, or who are considering becoming pregnant while in the study. 4. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol. 5. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB017 in subjects originally treated in Study 105MS301 who continue BIIB017 treatment.;Secondary Objective: The secondary objectives of this study are to describe long-term MS outcomes in subjects originally treated in Study 105MS301 who continue BIIB017 treatment.;Primary end point(s): The primary endpoints include the incidence of AEs, serious AEs (SAEs), and discontinuations of study treatment due to an AE, as well as the incidence of laboratory abnormalities.;Timepoint(s) of evaluation of this end point: As Necessary | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Relapse outcomes: - The annualized relapse rate (ARR) - The proportion of subjects who relapse MRI outcomes: - The total number of new or newly enlarging T2 hyperintense lesions on brain MRI scans - The number of new active lesions on brain MRI scans - The total number of new T1 hypointense lesions on brain MRI scans - The number of Gadolinium (Gd)-enhancing lesions on brain MRI scans - The volume of T2 hyperintense lesions on brain MRI scans - The volume of T1 hypointense lesions on brain MRI scans - The volume of Gd-enhancing lesions on brain MRI scans Whole brain atrophy Disability outcomes: - The degree of disability as measured by the EDSS - Disability progression (as measured by at least a 1.0 point increase on the EDSS from baseline EDSS =1.0 that is sustained for 24 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks) - Cognitive function as reflected by the SDMT Quality of Life outcomes: - The MSIS-29 physical score - The SF-12 - The Euro Quality of Life (EQ-5D) Other outcomes: - The number of relapses requiring intravenous (IV) steroid use - The number of MS-related hospitalizations - Percent of subject-reported treatment satisfaction;Timepoint(s) of evaluation of this end point: As Necessary | — |
Countries
Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Estonia, France, Germany, Greece, India, Latvia, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactNot Available at this time
Biogen Idec Limited
Outcome results
None listed