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Interferon

Peginterferon Beta-1a for Multiple Sclerosis

Phase 3
Recruiting
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have an EDSS score between 0.0 and 5.5
Must have experienced >= 1 relapse in the 12 months prior to randomization (Day 1) or >= 2 relapses in the 24 months prior to randomization (Day 1) or have evidence of asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior to randomization (Day 1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 96), weeks 108, 120, 132, 144,156, 168, 180, 192, and 196
Awards & highlights

Study Summary

This trial will study a new MS drug in children to see if it is safe and effective. Part 1 will assess how the drug works in the body, and Part 2 will evaluate long-term safety and effectiveness.

Who is the study for?
This trial is for children with relapsing-remitting multiple sclerosis (RRMS). They should have had at least one MS flare-up in the past year or show signs of disease activity on an MRI. Participants must be able to walk (EDSS score 0.0-5.5) and not have progressive forms of MS, severe allergies, or recent relapses.Check my eligibility
What is being tested?
The study tests BIIB017's safety and how well it works in kids with RRMS over two parts: first assessing its immediate effects and pharmacokinetics, then looking at long-term safety and MS outcomes after completing initial treatment.See study design
What are the potential side effects?
Possible side effects include reactions similar to flu symptoms, injection site reactions, liver problems, depression or mood swings, blood cell count changes, seizures, heart problems like congestive heart failure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disability score is between 0.0 and 5.5.
Select...
My condition has worsened or shown activity recently.
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I have been diagnosed with relapsing-remitting MS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 96), weeks 108, 120, 132, 144,156, 168, 180, 192, and 196
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 96), weeks 108, 120, 132, 144,156, 168, 180, 192, and 196 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Annualized Relapse Rate (ARR) at Week 48
Part 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Treatment Discontinuation
Secondary outcome measures
Part 1: ARR at Week 96
Part 1: Area Under the Plasma Concentration-Time Curve from Time Zero to End of Dosing Interval (AUCtau) for BIIB017
Part 1: Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Weeks 48, 96, and 100
+37 more

Side effects data

From 2013 Phase 3 trial • 1516 Patients • NCT00906399
56%
Injection Site Erythema
47%
Influenza Like Illness
44%
Pyrexia
41%
Headache
22%
Multiple Sclerosis Relapse
19%
Myalgia
18%
Chills
14%
Nasopharyngitis
14%
Asthenia
13%
Back Pain
13%
Injection Site Pain
11%
Arthralgia
11%
Pain In Extremity
11%
Injection Site Pruritus
11%
Fatigue
9%
Nausea
7%
Body Temperature Increased
7%
Vomiting
6%
Hypoaesthesia
6%
Pain
6%
Vertigo
6%
Urinary Tract Infection
5%
Hyperthermia
5%
Cough
5%
Depression
5%
Oropharyngeal Pain
5%
Muscular Weakness
4%
Alanine Aminotransferase Increased
4%
Insomnia
4%
Dizziness
4%
Paraesthesia
4%
Diarrhoea
3%
Upper Respiratory Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Year 1: Placebo
Year 1: Peginterferon Beta-1a Q4W
Year 1: Peginterferon Beta-1a Q2W
Year 2: Placebo Followed by Peginterferon Beta-1a Q4W
Year 2: Placebo Followed by Peginterferon Beta-1a Q2W
Year 2: Peginterferon Beta-1a Q4W
Year 2: Peginterferon Beta-1a Q2W

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BIIB017 (peginterferon beta-1a)Experimental Treatment1 Intervention
Participants will receive subcutaneous (SC) injection of BIIB017 (peginterferon beta-1a) 63 microgram (μg) on Day 1, followed by 94 μg at Week 2, followed by 125 μg at Week 4, and then 125 μg SC injection every 2 weeks up to Week 96 in Part 1 of the study. Eligible participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks.
Group II: AvonexActive Control1 Intervention
Participants will receive Avonex (interferon beta type 1a) starting at a dose of 7.5 μg on Day 1, followed by an increase of 7.5 μg each week for 3 weeks, followed by 30 μg intramuscular (IM) injections every week up to Week 96 in Part 1 of the study. Eligible participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIIB017 (peginterferon beta-1a)
2009
Completed Phase 3
~1520

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,294 Total Patients Enrolled
226 Trials studying Multiple Sclerosis
142,190 Patients Enrolled for Multiple Sclerosis
Medical DirectorStudy DirectorBiogen
2,770 Previous Clinical Trials
8,061,918 Total Patients Enrolled
136 Trials studying Multiple Sclerosis
126,257 Patients Enrolled for Multiple Sclerosis

Media Library

BIIB017 (peginterferon beta-1a) (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT03958877 — Phase 3
Multiple Sclerosis Research Study Groups: BIIB017 (peginterferon beta-1a), Avonex
Multiple Sclerosis Clinical Trial 2023: BIIB017 (peginterferon beta-1a) Highlights & Side Effects. Trial Name: NCT03958877 — Phase 3
BIIB017 (peginterferon beta-1a) (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03958877 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the requirements for this trial limiting it to a specific age group?

"This particular research study is focused on children aged 10-18."

Answered by AI

Am I an eligible candidate for this research?

"The current clinical trial has a set of inclusion criteria that requires potential participants to have multiple sclerosis, be in an acute relapsing state, and be between the ages of 10 and 18. Up to 142 patients will be accepted into the trial."

Answered by AI

Are there any risks associated with BIIB017 (peginterferon beta-1a)?

"BIIB017 (peginterferon beta-1a) has been studied in Phase 3 trials, meaning that there is both safety and efficacy data available. Our team rates it as a 3 on our safety scale."

Answered by AI

What purpose does BIIB017 (peginterferon beta-1a) serve most often?

"BIIB017 is most often used as part of a parenteral drug administration therapy regimen. It has also shown efficacy in treating multiple sclerosis, carcinoma in situ, and parenteral drug administration."

Answered by AI

What is the efficacy of BIIB017 in other medical research?

"25 studies are currently underway to study the efficacy of BIIB017 (peginterferon beta-1a), 13 of which are in Phase 3. The trials for BIIB017 are largely based in Milwaukee, Wisconsin, but there are 1,555 locations across the globe conducting these experiments."

Answered by AI
~79 spots leftby Nov 2029