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Immunomodulator

Rebif® for Multiple Sclerosis

Phase 4
Waitlist Available
Research Sponsored by EMD Serono
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 96 weeks
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group
Drug Has Already Been Approved

Summary

The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

Eligible Conditions
  • Multiple Sclerosis

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to First Relapse

Side effects data

From 2016 Phase 4 trial • 200 Patients • NCT02064816
50%
Influenza Like Illness
22%
Headache
14%
Pyrexia
13%
Injection Site Erythema
10%
Nausea
10%
Myalgia
9%
Fatigue
7%
Asthenia
5%
Arthralgia
5%
Injection Site Pain
4%
Pain In Extremity
4%
Aspartate Aminotransferase Increased
4%
Transaminases Increased
4%
Alanine Aminotransferase Increased
3%
Multiple Sclerosis Relapse
2%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rebif Morning Administration
Rebif Evening Administration

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Rebif®Experimental Treatment1 Intervention
Group II: Copaxone®Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interferon beta-1a
FDA approved

Find a Location

Who is running the clinical trial?

EMD SeronoLead Sponsor
145 Previous Clinical Trials
27,015 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
10,521 Patients Enrolled for Multiple Sclerosis
PfizerIndustry Sponsor
4,649 Previous Clinical Trials
17,743,612 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
52,472 Patients Enrolled for Multiple Sclerosis
Medical ResponsibleStudy DirectorMerck KGaA, Darmstadt, Germany
298 Previous Clinical Trials
60,161 Total Patients Enrolled
42 Trials studying Multiple Sclerosis
16,069 Patients Enrolled for Multiple Sclerosis
~35 spots leftby Oct 2025
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