About the CHARGE clinical trial

Overview

Current treatment options for children with relapsing-remitting multiple sclerosis (RRMS) are limited.

That's why we're conducting the CHARGE trial - we want to make sure that the investigational use of a drug is safe and effective for children with RRMS. This drug is BIIB017. But it is also known as peginterferon beta-1a.

This section will tell you more about this trial, but if you’re ready to take the next step please complete our short pre-screener. We will tell you if your child may be suitable and the location of your nearest participating clinic.

About the investigational drug

What drug is being investigated in this trial?

We are investigating a drug called BIIB017 (also known as peginterferon beta-1a).

How does peginterferon beta-1a work?

BIIB017 is thought to work by reducing the inflammation caused in MS.

A clinical trial investigating BIIB017 (peginterferon beta-1a) in children (ages 10-17) with relapsing-remitting multiple sclerosis.

CHARGE is an open-label, active controlled clinical trial that will assess the safety and effectiveness of BIIB017 (peginterferon beta-1a) in children with relapsing-remitting multiple sclerosis (RRMS).

But what exactly does this mean?

Well, an open-label trial is one where the participants know which treatment they are being given. So in the CHARGE trial, each child (and their family) will know whether they have been given peginterferon beta-1a or the active-control.

An active control is a drug that the investigational drug is compared with. In the CHARGE trial, the active control is a drug called interferon beta-1a.

At this time, we don't know if or how well peginterferon beta-1a works in children with RRMS. To find out, children participating in the CHARGE trial will be randomly assigned to receive either peginterferon beta-1a or interferon beta-1a so that we can compare the results.

Who can take part?

We’re looking for 142 children to take part in the CHARGE trial. To be eligible, each must (among other things):

  • Be aged 10-17
  • Have confirmed RRMS
  • Have evidence of disease activity defined as either:
    • Active lesions seen on an MRI scan within the last six months
    • At least one relapse within the last year
    • At least two relapses within the last two years

To find out if your child may be suitable please complete our short pre-screener.

Please note that other eligibility criteria apply.

Clinical trial length

The CHARGE clinical trial will last for around two years in total, but eligible children may choose to remain in the trial for about four years.

Screening (Up to 1 month)

We’ll carry out some tests to make sure that the study is right for you.

Treatment Period (22 months)

If it is, you’ll be randomly given either:

Group 1 (71 Children)

BIIB017 injections

GROUP 2 (71 children)

interferon beta-1a injections

OPTIONAL TREATMENT PERIOD (22 months)

You’ll be given BIIB017 injections

FOLLOW-UP (1 month after your last dose)

You’ll need to come for one final check-up so we can make sure you’re OK.

visual diagram representing the trial length

Visits

During this trial, participants will visit a clinic around 13 times. These visits will take place about once every 2-4 weeks and will allow us to monitor your child’s general health and the status of your child’s condition.

Assessments will vary from visit-to-visit, but may include:

  • Body
    measurements
  • Blood tests
     
  • MRI scans
     
  • Urine samples
     
  • Heart checks
     
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