To determine if BIIB017 is safe and tolerable enough in patients with Relapsing Multiple Sclerosis on a long term duration.
- Conditions
- Health Condition 1: null- Multiple Sclerosis
- Registration Number
- CTRI/2011/12/002229
- Lead Sponsor
- Biogen Idec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1500
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measures: <br/ ><br>The incidence of adverse events and lab abnormalities as a measure of the long-term safety and tolerability of BIIB017Timepoint: 2 Years
- Secondary Outcome Measures
Name Time Method â?¢MS outcomes assessed using the annualized relapse rate (ARR) <br/ ><br>â?¢MRI outcomes assessed using the number and volume of brain lesions [ Time Frame: 2 years ] <br/ ><br>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 <br/ ><br>Timepoint: Time Frame: 2 years