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 - ATTAI

Biogen Idec Limited0 sites1,600 target enrollmentMarch 20, 2012

ConditionsRelapsing Multiple Sclerosis MedDRA version: 17.1Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsing Multiple Sclerosis
Sponsor: Biogen Idec Limited
Enrollment: 1600
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 20, 2012

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Biogen Idec Limited

Eligibility 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 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.