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

NCT01181115 | Completed Phase 3

• 1 other identifier: 108MS301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Multiple Sclerosis

Keywords

Chinese Patients; Relapsing MS; Safety; Avonex; Tolerability; Gadolinium; Interferon Beta 1a

Outcome Measures

Primary Outcomes (9)

• The number and proportion of subjects with adverse events (AEs)

  24 weeks

• Assessment of clinical laboratory parameters

  24 weeks

• Assessment of vital signs and physical examinations

  24 weeks

• Assessment of electrocardiogram (ECG)

  24 weeks

• Assessment of immunogenicity

  24 weeks

• Incidence of depression

  24 weeks

• Incidence of flu-like symptoms

  24 weeks

• Subject assessment of injection site pain

  24 weeks

• Clinical assessment of the injection site

  24 weeks

Secondary Outcomes (5)

• Assess safety of Avonex by evaluating changes in the Expanded Disability Status Scale (EDSS) score over time

  24 weeks

• Number of Gd-enhancing lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment

  at month 3 and month 6

• Number of new or newly enlarging T2-weighted lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment

  at month 3 and month 6

• Volume of T2-weighted lesions on brain MRI scans taken after 6 months following initiation of Avonex treatment

  month 6

• Assess pharmacodynamic response to Avonex by evaluating the change from baseline in serum levels of neopterin

  24 weeks

Study Arms (1)

Active treatment

EXPERIMENTAL

Interferon treatment for MS

Drug: Avonex

Interventions

Avonex DRUG

Interferon treatment for MS

Active treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Biogen: lead

Study Sites (10)

Research Site

Baotou, China

Location

Research Site

Beijing, China

Location

Research Site

Changchun, China

Location

Research Site

Chengdu, China

Location

Research Site

Guangzhou, China

Location

Research Site

Hangzhou, China

Location

Research Site

Nanchang, China

Location

Research Site

Shanghai, China

Location

Research Site

Taiyuan, China

Location

Research Site

Xi'an, China

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 13, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 16, 2013

Record last verified: 2011-11

Locations

CN (10)