Health Condition 1: null- Multiple Sclerosis
Conditions
Interventions
Intervention1: BIIB 17: BIIB017 is supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 mcg dose) of 20 kDa mPEG-O-2-methylpropionaldehyde-modified human IFN β-1a in 20 mM
Sponsors
Biogen Idec
Biogen Idec Biotech India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulationsSubjects who participated in Study 105MS301 who completed the study treatment and visit schedule through Week 96 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.
Exclusion criteria
Exclusion criteria: Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301 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 subjects ability to comply with the protocol. 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 |
|---|---|
| Primary Outcome Measures: The incidence of adverse events and lab abnormalities as a measure of the long-term safety and tolerability of BIIB017Timepoint: 2 Years | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ MS outcomes assessed using the annualized relapse rate (ARR) â?¢ MRI outcomes assessed using the number and volume of brain lesions [ Time Frame: 2 years ] â?¢ Disability outcomes assessed using the Expanded Disability Status Score (EDSS) and Symbol Digit Modalities Test (SDMT) Quality of Life assessed using the SF-12, EQ-5D, and MSIS-29 Timepoint: Time Frame: 2 years | — |
Countries
Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Estonia, France, Georgia, Germany, Greece, India, Latvia, Mexico, Netherlands, New Zealand, Peru, Poland, Russian Federation, Serbia, Spain, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Ritika Bajaj
Biogen
Outcome results
None listed