A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
- Conditions
- Relapsing Multiple Sclerosis10012303
- Registration Number
- NL-OMON39656
- Lead Sponsor
- Biogen Idec LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
1. Subjects who participated in Study 105MS301, who completed the study treatment and visit schedule through Week 96.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints: The incidence of adverse events (AEs), serious AEs (SAEs),<br /><br>and discontinuations of study treatment due to an AE, as well as the incidence<br /><br>of laboratory abnormalities.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints: Secondary endpoints include MS relapse outcomes, MRI<br /><br>outcomes, disability outcomes, Quality of Life (QoL), and other outcomes<br /><br>assessed over the 2-year period of the study.</p><br>