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Immunomodulator

Peginterferon Beta-1a 125 µg for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 48 and 96
Awards & highlights

Study Summary

This study is evaluating whether two medications may help reduce the symptoms of multiple sclerosis.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 48 and 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 48 and 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to First Relapse
Secondary outcome measures
Annualized Relapse Rate
Number of Galdolinium (Gd)-Enhancing Lesions at Weeks 48 and 96
Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans at Weeks 48 and 96
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Peginterferon Beta-1a 125 µgExperimental Treatment1 Intervention
Participants will receive peginterferon beta-1a 125 micrograms (µg) SC injection every 2 weeks and placebo capsule BID orally for up to 96 weeks (2 years).
Group II: Dimethyl Fumarate 240 mgExperimental Treatment1 Intervention
Participants will receive dimethyl fumarate 240 milligrams (mg) capsule twice daily (BID) orally and placebo subcutaneous (SC) injection every 2 weeks for up to 96 weeks (2 years).
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo SC injection every 2 weeks and placebo capsule BID orally for up to 96 weeks (2 years)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dimethyl Fumarate
2015
Completed Phase 3
~1000
Peginterferon Beta-1a
2013
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,311 Total Patients Enrolled
226 Trials studying Multiple Sclerosis
142,207 Patients Enrolled for Multiple Sclerosis
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,064,208 Total Patients Enrolled
136 Trials studying Multiple Sclerosis
126,348 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
2019. "Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03870763.
~2 spots leftby Apr 2025
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