Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dimethyl Fumarate
CAS Number: 624497
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 and completed as per protocol previous BG00012 clinical studies 109MS301 or 109MS302, including those subjects who received an open-label, approved MS therapy and completed the modified visit schedule. 3. All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of BG00012. 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 1738 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any significant change in medical history in subjects from 109MS301 or 109MS302, including laboratory tests, or current clinically significant condition that in the opinion of the Investigator would have excluded the subjects' participation from their previous study. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment. 2. Subjects from 109MS301 or 109MS302 who discontinued BG00012 due to an AE or due to reasons other than protocol-defined relapse/disability progression. 3. Subjects from 109MS301 or 109MS302 who discontinued study BG00012 due to disability progression or relapses and did not follow the modified visit schedule up to Week 96. 4. History of malignancy. 5. History of severe allergic or anaphylactic reactions. 6. Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyltransferase (GGT) >3 times the upper limit of normal (ULN). 7. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding. 8. Previous participation in this study (109MS303). 9. 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. 10. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety profile of BG00012.; Secondary Objective: To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (Expanded Disability Status Scale). To evaluate further the long-term effects of BG00012 on MS brain lesions on MRI scans in subjects who had MRI scans as part of Studies 109MS301 and 109MS302 and in 109MS303 up through and including Amendment6. The following MRI endpoints will be evaluated in the subset of subjects who participated in the MRI scans: number and volume of Gd-enhancing lesions, number of new or newly enlarging T2 lesions and volume of total T2 lesions, number of new T1 hypointense lesions and volume of T1 hypointense lesions, brain atrophy, and magnetization transfer ratio (MTR). To evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. The endpoints are the SF-36 and EQ-5D quality of life questionnaire, and the visual function test scores. ;Primary end point(s): The primary objective and endpoint is to evaluate the long-term safety profile of BG00012.;Timepoint(s) of evaluation of this end point: The safety analysis will focus on the 8-year safety data in the extension study. For subjects who were dosed with BG00012 in the previous study, long-term safety data (extension study + 2 years) may also be summarized. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary end points will be evaluated for the 8 years in the extension phase and for some the extension study + 2 years starting from the original baseline of the Phase 3 studies (109MS301 and 109MS302).; Secondary end point(s): • To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (EDSS). • To evaluate further the long-term effects of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (EDSS). • To evaluatre further the long-term effects of BG00012 on MS brain lesions on MRI scans in subjects who had MRI scans as part of Studies 109MS301 and 109MS302 and in 109MS303 up through and including Amendment6. The following MRI endpoints will be evaluated in the subset of subjects who participated in the MRI scans: number and volume of Gd-enhancing lesions, number of new or newly enlarging T2 lesions and volume of total T2 lesions, number of new T1 hypointense lesions and volume of T1 hypointense lesions, brain atrophy, and MTR. • To evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. The endpoints are the SF-36 and EQ-5D quality of life questionnaire, and the visual function test scores. | — |
Countries
Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Estonia, France, Germany, Greece, Guatemala, India, Ireland, Israel, Italy, Latvia, Macedonia, the former Yugoslav Republic of, Mexico, Moldova, Republic of, Netherlands, New Zealand, Poland, Romania, Serbia, Slovakia, South Africa, Spain, Switzerland, Ukraine, United Kingdom, United States
Outcome results
None listed