Study on the Safety and Effectiveness of Peginterferon Beta-1a for Children and Teens with Relapsing-Remitting Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying a condition called Relapsing-Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis where patients experience episodes of new or worsening symptoms followed by periods of recovery. The study is testing a treatment called BIIB017, also known as Peginterferon beta-1a. This medication is given as an injection and is designed to help manage the symptoms of RRMS.

The purpose of the study is to evaluate the safety and effectiveness of BIIB017 in children and teenagers aged 10 to less than 18 years who have RRMS. Participants in the study will receive either the study medication or a different treatment for comparison. The study will be conducted in two parts. In the first part, the focus will be on understanding how the body processes the medication and its immediate effects. In the second part, the study will look at the long-term safety and outcomes of using BIIB017 over an extended period.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. This will include assessments of their symptoms, overall well-being, and any side effects they may experience. The study aims to provide valuable information on how BIIB017 can be used to treat RRMS in younger patients, helping to improve their quality of life and manage their symptoms more effectively.

1 initial treatment phase

The study begins with the administration of BIIB017 (peginterferon beta-1a) to participants diagnosed with relapsing-remitting multiple sclerosis (RRMS).

Participants receive Plegridy 63 micrograms and 94 micrograms solution for injection in a pre-filled pen, administered subcutaneously. This phase aims to evaluate the safety and tolerability of the medication.

2 dose adjustment phase

Participants transition to a higher dose of Plegridy 125 micrograms solution for injection in a pre-filled pen, administered subcutaneously.

This phase continues to monitor safety and begins to assess the efficacy of the treatment over a period of 96 weeks.

3 monitoring and assessment

Throughout the study, participants undergo regular assessments to monitor the annualized relapse rate (ARR) and the presence of new or enlarging lesions on brain MRI scans.

Additional evaluations include changes in cognition, quality of life, and various physical health parameters such as blood pressure, pulse rate, and body temperature.

4 long-term safety evaluation

Participants who complete the initial 96-week treatment phase may enter an optional extension phase to further evaluate the long-term safety of BIIB017.

This phase extends the monitoring period to assess the continued impact of the treatment on multiple sclerosis outcomes and any adverse events.

5 final assessments

At the conclusion of the study, final assessments are conducted to evaluate the overall safety and efficacy of the treatment.

Participants’ health metrics, including any changes in clinical laboratory values and the presence of antibodies, are thoroughly reviewed.

Who Can Join the Study?

The patient must have a diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis where symptoms come and go.
The patient must have an EDSS score between 0.0 and 5.5. The EDSS score is a way to measure how much the disease affects the patient’s ability to move and do daily activities.
The patient must have experienced at least one relapse (a return of symptoms) in the 12 months before starting the study, or at least two relapses in the 24 months before starting the study. Alternatively, the patient can have signs of the disease without symptoms, shown by Gd-enhancing lesions on a brain MRI in the 6 months before starting the study. Gd-enhancing lesions are areas in the brain that show up on an MRI scan when a special dye is used, indicating active disease.
For Part II of the study, the patient must have completed the study treatment in Part I, which means they attended the Week 96 Visit as required by the study plan.
The study is open to both male and female patients.
The study includes patients who are considered part of a vulnerable population, meaning they may need extra protection or care.

Who Cannot Join the Study?

Participants who have any other serious health condition that could interfere with the study.
Participants who are currently taking other medications that might affect the study results.
Participants who have had a recent infection or illness that could impact their participation.
Participants who have a history of allergic reactions to similar medications.
Participants who are unable to follow the study procedures or attend scheduled visits.
Participants who have participated in another clinical trial recently.
Participants who are pregnant or breastfeeding.
Participants who have a history of substance abuse or addiction.
Participants who have any condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Narodny Ustav Detskych Chorob	Bratislava	Slovakia
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD	Sofia	Bulgaria
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Shbrqecnui Edobirtj Gmejcaslqhjfuhtjyb Kjqksld	Budapest	Hungary

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	31.10.2019
Croatia	Not recruiting	31.10.2019
Czechia	Not recruiting	31.10.2019
Hungary	Not recruiting	31.10.2019
Slovakia	Not recruiting	31.10.2019

Trial locations

Investigated drugs:

BIIB017 is a medication being studied for its safety, tolerability, and effectiveness in treating pediatric patients with relapsing-remitting multiple sclerosis (RRMS). The trial aims to understand how well children aged 10 to less than 18 years respond to this treatment. The study also looks at how the body processes the medication over time. In the second part of the study, researchers will continue to monitor the long-term safety and effects of the medication on multiple sclerosis outcomes for those who completed the initial treatment phase.

Investigated diseases:

Relapsing-remitting multiple sclerosis

Relapsing-Remitting Multiple Sclerosis (RRMS) – This is a type of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During these relapses, the immune system mistakenly attacks the protective covering of nerve fibers, causing inflammation and damage. The periods of remission can last for weeks, months, or even years, during which symptoms may improve or disappear. Over time, some individuals may experience a gradual worsening of symptoms, even between relapses. The disease can affect various functions, including vision, balance, and muscle control, depending on which nerves are affected. RRMS is the most common form of multiple sclerosis at the time of diagnosis.

Trial ID:

2023-505624-56-00

Protocol code:

105MS306

NCT ID:

NCT03958877

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Peginterferon Beta-1a for Children and Teens with Relapsing-Remitting Multiple Sclerosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?