Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS) (Avonex China)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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|
- The number and proportion of subjects with adverse events (AEs) [ Time Frame: 24 weeks ]
- Assessment of clinical laboratory parameters [ Time Frame: 24 weeks ]
- Assessment of vital signs and physical examinations [ Time Frame: 24 weeks ]
- Assessment of electrocardiogram (ECG) [ Time Frame: 24 weeks ]
- Assessment of immunogenicity [ Time Frame: 24 weeks ]
- Incidence of depression [ Time Frame: 24 weeks ]
- Incidence of flu-like symptoms [ Time Frame: 24 weeks ]
- Subject assessment of injection site pain [ Time Frame: 24 weeks ]
- Clinical assessment of the injection site [ Time Frame: 24 weeks ]
- Assess safety of Avonex by evaluating changes in the Expanded Disability Status Scale (EDSS) score over time [ Time Frame: 24 weeks ]
- 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 ]
- 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 ]
- Volume of T2-weighted lesions on brain MRI scans taken after 6 months following initiation of Avonex treatment [ Time Frame: month 6 ]
- Assess pharmacodynamic response to Avonex by evaluating the change from baseline in serum levels of neopterin [ Time Frame: 24 weeks ]
|Study Start Date:||April 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Active treatment
Interferon treatment for MS
Interferon treatment for MS
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181115