To determine if treatment with BIIB017 can decrease the number of MS relapses during a certain time period for patients with RMS. Other goals of the study are to determine if, over time, BIIB017 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.

Phase 3

Completed

Brief Summary: This study is a multicenter, randomized, double-blind, parallel- group, placebo- controlled study to evaluate the efficacy and safety of PEGylated Interferon Beta-1a (BIIB017) (125 mcg SC) in two dosing frequencies (every 2 weeks and every 4 weeks) in subjects with relapsing multiple sclerosis. The study will be conducted in approximately 30 countries and approximately 225 sites globally. Approximately 1260 subjects are planned to participate in this trial. The primary outcome measure is to determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo. The secondary outcomes are to determine whether BIIB017, at 1 year when compared with placebo, is effective in reducing the total number new brain lesions, reducing the proportion of subjects who relapsed, improving quality of life, and slowing the progression of disability. India has contributed 170 patients and all the patients are in the follow up phase of the study.

Recruitment & Eligibility

Inclusion Criteria

Aged 18 to 65 years old, inclusive, at the time of informed consent.
Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-4.
Must have an EDSS score between 0.0 and 5.0. 4.
Must have experienced at least 2 relapses that have been medically documented within the last 3 years with one occurring in the last 12 months.

Exclusion Criteria

Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease 2.
Pregnant or nursing women Other protocol-defined, Inclusion/ exclusion criteria may apply.

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo.	1 year

Secondary Outcome Measures

Name	Time	Method
To determine whether BIIB017, at 1 year when compared with placebo, is effective in reducing the total number new brain lesions, reducing the proportion of subjects who relapsed, improving quality of life, and slowing the progression of disability.	1 year

Locations (21): All India Institute of Medical Sciences
🇮🇳
South, DELHI, India
Bangalore Clinisearch
🇮🇳
Bangalore, KARNATAKA, India
Brain And Mind Institute
🇮🇳
Nagpur, MAHARASHTRA, India
Brain Centre
🇮🇳
Mumbai, MAHARASHTRA, India
Clinical trial office, R. No-24, 2nd floor, Physiotherapy Dept.,Jaslok Hospital and Research Centre
🇮🇳
Mumbai, MAHARASHTRA, India
Curie Manavata Cancer Centre
🇮🇳
Nashik, MAHARASHTRA, India
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳
Pune, MAHARASHTRA, India
Deprt of Neurology, Poona Hospital and Research Centre
🇮🇳
Pune, MAHARASHTRA, India
Dept of Neurology, Sir Ganga Ram Hospital
🇮🇳
Delhi, DELHI, India
Dept. of Neurology, Manipal Hospital
🇮🇳
Bangalore, KARNATAKA, India
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All India Institute of Medical Sciences
🇮🇳South, DELHI, India
Dr Manjari Tripathi
Principal investigator
01126588248
manjari.tripathi@gmail.com