Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

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).
    

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.
    

Intervention name(s): Avonex
Intervention type(s): Drug
Intervention description(s): Interferon treatment for MS
Intervention MeSH terms: Interferon beta-1a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chinese Patients; Relapsing MS; Safety; Avonex; Tolerability; Gadolinium; Interferon Beta 1a