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Immunomodulator

teriflunomide for Multiple Sclerosis

Phase 4
Waitlist Available
Led By Stanley Cohan, MD, Ph. D
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
MAIN STUDY
Male and female patients, age 21 to 60 with relapsing forms of MS, treated with natalizumab for 12 consecutive months or longer with anti-JCV Ab positive during that time period.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing if teriflunomide will be safe and effective to prevent relapses in patients with relapsing types of MS who are switching from natalizumab.

Eligible Conditions
  • Multiple Sclerosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MAIN STUDY: Number of Participants Relapse Free at 24 Months
Secondary outcome measures
MAIN STUDY: Expanded Disability Status Scale (EDSS) Sustained Progression for 3 Months as Measured by at Least 0.5 Increase From Baseline or 1 in Any EDSS Set Score
MAIN STUDY: Mean Time to New T2 or Enlarging T2 Hyperintensities on Monthly Sentinel Brain MRIs
MAIN STUDY: Time to Return of Radiological Evidence of Multiple Sclerosis Activity With New Gadolinium "Enhancing" (Gd+) Lesions on Cranial MRI.

Side effects data

From 2022 Phase 4 trial • 55 Patients • NCT01970410
36%
Hair Thinning/ loss
33%
Diarrhea /loose stool
22%
Headache
20%
Nausea/vomiting
20%
Vertigo/balance difficulty/dizziness
18%
Fatigue
18%
Upper respiratory infection
18%
Tingling/paresthesia
15%
Elevated transaminase
15%
Extremity joint pain
15%
Other infections
15%
Sensory decrease/disturbance
15%
Cognitive changes
15%
Urinary tract infection
15%
Depression
13%
Rashes/eczema
11%
Abdominal pain/discomfort
11%
Anxiety
11%
Ophthalmic changes
9%
Decreased appetite
9%
Heartburn
9%
Hypertension
9%
Stiffness/spasticity
9%
Migraine
2%
Empyema
2%
Gangrenous appendicitis, ruptured
2%
Pleural effusion
2%
Pneumonia
2%
Pyelonephritis
2%
Right pneumothorax
2%
Squamous cell carcinoma, left ankle
2%
Subfalcial herniation
2%
Obstructive hydrocephalus
2%
Brain abscess
100%
80%
60%
40%
20%
0%
Study treatment Arm
MAIN STUDY: Teriflunomide
SUB-STUDY: Anti- John Cunningham Virus (JCV) Antibody Status

Trial Design

1Treatment groups
Experimental Treatment
Group I: TeriflunomideExperimental Treatment1 Intervention
Teriflunomide 14 mg oral teriflunomide daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
teriflunomide
2015
Completed Phase 4
~1320

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
115 Previous Clinical Trials
122,468 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
155 Patients Enrolled for Multiple Sclerosis
Multiple Sclerosis Center of Northeastern New YorkOTHER
4 Previous Clinical Trials
146 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
146 Patients Enrolled for Multiple Sclerosis
Stanley Cohan, MD, Ph. DPrincipal InvestigatorProvidence Multiple Sclerosis Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025