Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to determine the effect of weekly intramuscular (IM) administration of 30 mcg Avonex (interferon beta 1a) on safety parameters and gadolinium (Gd) enhanced and T2-weighted cranial magnetic resonance imaging (MRI) lesions in Chinese patients with clinically diagnosed (using revised McDonald criteria) relapsing multiple sclerosis (MS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Ability to understand risks of study and provide informed consent.

• Must be Chinese, aged 18 to 55 years inclusive at time of consent.

• Must have diagnosis of relapsing MS of 3 months duration at time of screening visit.

• Must have at least 1 documented MS attack within 3 years of Day 1.

• Must have EDSS score of 0 to 5 inclusive at screening visit.

• All male subjects & female subjects of child-bearing potential must practice effective contraception during the study.

Exclusion Criteria:

• Have a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS.

• Have had a clinical MS attack within the 50 days prior to Day 1, and or the subject has not stabilized from a previous attack in the opinion of the Investigator.

• The subject is unable to undergo a brain MRI scan for any reason.

• The subject's screening and Day 1 MRIs are both normal (negative) for lesions consistent with MS (Gd-enhancing lesions are not required, but one of the 2 MRIs should be consistent with MS).

• History of severe allergic or anaphylactic reactions.

• Known allergy to any component of the Avonex Formulation.

• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease.

• Subjects with a history of malignant disease, including solid tumors, and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and considered cured).

• History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Day 1.

• History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 6 months prior to Day 1. Note: subjects receiving ongoing antidepressant therapy will not be excluded from the study unless the medication has been increased within the 6 months prior to Day 1.

• Clinically significant abnormal ECG values as determined by the Investigator.

• Known history of human immunodeficiency virus (HIV).

• Known history of, or positive test result for hepatitis C virus (test for hepatitis C virus antibody HCV Ab) or hepatitis B virus (test for Hepatitis B surface Antigen HBsAg) and/or Hepatitis B Core Antibody (HBcAb).