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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01181115
First received: August 5, 2010
Last updated: September 12, 2013
Last verified: November 2011
  Purpose

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).


Condition Intervention Phase
Multiple Sclerosis
Drug: Avonex
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • The number and proportion of subjects with adverse events (AEs) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of clinical laboratory parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of vital signs and physical examinations [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of electrocardiogram (ECG) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of immunogenicity [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of depression [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of flu-like symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Subject assessment of injection site pain [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Clinical assessment of the injection site [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess safety of Avonex by evaluating changes in the Expanded Disability Status Scale (EDSS) score over time [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of Gd-enhancing lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment [ Time Frame: at month 3 and month 6 ] [ Designated as safety issue: No ]
  • Number of new or newly enlarging T2-weighted lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment [ Time Frame: at month 3 and month 6 ] [ Designated as safety issue: Yes ]
  • Volume of T2-weighted lesions on brain MRI scans taken after 6 months following initiation of Avonex treatment [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
  • Assess pharmacodynamic response to Avonex by evaluating the change from baseline in serum levels of neopterin [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active treatment
Interferon treatment for MS
Drug: Avonex
Interferon treatment for MS

Detailed Description:

This is a multicenter, open-label, safety study to support registration of Avonex in China by providing data on the effect of weekly IM administration of 30mcg Avonex on safety parameters in Chinese patients with clinically diagnosed relapsing MS. This study will also include an intra-subject exploratory comparison of pre-treatment MRI (at -3 months and at month 0) and post -treatment MRI (at month 3 and month 6). Up to 60 subjects with relapsing forms of MS will be recruited to approximately 6 sites in China.

The study period will consist of screening, a 6 month open-label treatment period, and follow up at 30 days post-dosing. There will be a total of 8 clinic visits and 1 telephone contact.

Screening: will be determined 3 months +/- 7 days prior to subjects' first dose of Avonex on Day 1, at which time a screening MRI with and without Gd-enhancement will be performed.

Treatment Period: consists of eligible patients undergoing pre-dosing assessments and receiving the first dose of Avonex on day 1. Subjects will have a brain MRI within 48 hours prior to the first injection of Avonex.

Weekly doses of open-label Avonex 30mcg IM will be administered for 24 consecutive weeks for a total of 25 injections per subject. Subjects or their caregivers will be allowed to self-inject after successful completion of appropriate IM injection training.

Subjects will return to the clinic at weeks 6, 12, 18 and 24 for safety and laboratory assessments (including blood sample collection for pharmacodynamic (neopterin) and immunogenicity testing), and clinician injection site assessments. Subjects will undergo brain MRI with and without Gd enhancement at week 12 and week 24. Subjects will perform injection site pain assessments on day 1 and at weeks 6, 12, 18, and 24 recording results on a visual analog scale. Subjects who prematurely discontinue Avonex may remain in the study and continue protocol-scheduled visits/evaluations (with the exception of subject and clinician injection site assessments and neopterin sample collection.

Subjects who experience new or worsening symptoms suggestive of an MS relapse will have a neurological worsening visit within 5 days following onset of symptoms. Treatment of confirmed MS relapses will follow a protocol-specified regimen.

Post treatment period: subjects will undergo follow-up assessment at week 24 (at 24+/- 8 hours following their last Avonex injection, if applicable). Subjects will have a telephone follow up contact conducted 30 (+/- 7 days) after their last study visit to assess AEs and use of concomitant medications.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181115

Locations
China
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Chengdu, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
Research Site
Nanchang, China
Research Site
Shanghai, China
Research Site
Taiyuan, China
Research Site
Xi'an, China
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01181115     History of Changes
Other Study ID Numbers: 108MS301
Study First Received: August 5, 2010
Last Updated: September 12, 2013
Health Authority: China: State Food and Drug Administration (FDA)

Keywords provided by Biogen Idec:
Chinese Patients
Relapsing MS
Safety
Avonex
Tolerability
Gadolinium
Interferon Beta 1a

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta 1a
Interferon-beta
Interferons
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014