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.

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis. Acronym: ADVANCE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000690

Enrollment

1500

Registered

2009-10-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Relapsing Multiple Sclerosis

Interventions

Intervention1: BIIB017: 125 mcg BIIB017 SC every 2 weeks for 96 weeks Intervention2: BIIB017: 125 mcg BIIB017 SC every 4 weeks for 96 weeks Control Intervention1: Placebo: SC Placebo every 2 weeks for

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old, inclusive, at the time of informed consent. 2. Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-4. 3. 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

Exclusion criteria: 1. Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease 2. Pregnant or nursing women Other protocol-defined, Inclusion/ exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
To determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo.Timepoint: 1 year	—

Secondary

Measure	Time frame
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.Timepoint: 1 year	—

Countries

India

Contacts

Public ContactMamta Madaan

Biogen Idec Biotech India Pvt. Ltd.

anjali.nagpal@biogenidec.com0124-4572304

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026