A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1600

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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method

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