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Early Aggressive vs Traditional Therapy for Multiple Sclerosis (TREAT-MS Trial)

N/A
Recruiting
Led By Ellen M. Mowry, MD, MCR
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-60 years
Meets 2017 McDonald criteria for relapsing-remitting MS [patients with clinically isolated syndrome (CIS) are not eligible]
Timeline
Screening 1 day
Treatment 84 months
Follow Up from 6 months after starting 1st therapy up to 75 months after randomization
Awards & highlights

Summary

This trial will help researchers understand if an early aggressive therapy approach is better than a traditional first-line therapy approach for preventing long-term disability in MS patients.

Who is the study for?
This trial is for adults aged 18-60 with relapsing-remitting Multiple Sclerosis who meet specific criteria and have not had chemotherapy in the past year. They must test negative or low positive for JC virus, and negative for Hepatitis B/C, tuberculosis, and HIV.Check my eligibility
What is being tested?
The TREAT-MS trial compares two approaches: 'early aggressive' therapy versus traditional first-line treatments to see which better prevents long-term disability in MS patients at different risk levels of disability accumulation.See study design
What are the potential side effects?
Early aggressive therapy may increase the risk of infections and other complications due to its higher efficacy compared to traditional therapies. The exact side effects will depend on the specific treatments used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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You meet 2017 McDonald criteria for relapsing-remitting MS.
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I don't have JC virus, hepatitis B or C, or tuberculosis.
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You are HIV negative.
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I haven't had chemotherapy in the last year and if I had cancer before, my doctor has noted why stronger treatment is needed.

Timeline

Screening ~ 1 day
Treatment ~ 84 months
Follow Up ~from 6 months after starting 1st therapy up to 75 months after randomization
This trial's timeline: 1 day for screening, 84 months for treatment, and from 6 months after starting 1st therapy up to 75 months after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Overall Burden of MS
Time to sustained disability progression
Secondary outcome measures
Adverse event resulting in a decision to change disease-modifying therapy
Cognition using Symbol Digit Modality Test (SDMT)
Employment status
+23 more
Other outcome measures
Brain Magnetic Resonance Imaging (MRI) evidence of neurodegeneration
Brain
Pharmaceutical Preparations
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Traditional TherapyActive Control1 Intervention
First-line disease-modifying therapy (Traditional Therapy) for treatment of multiple sclerosis Traditional Therapy choices and maximum allowable doses: Glatiramer acetate (Copaxone, Glatopa, and other generics), 20 mg subcutaneously (SC) daily, or 40 mg SC three times a week Intramuscular interferon (Avonex), 30 mcg intramuscularly (IM) weekly Subcutaneous interferon (Betaseron, Extavia, Rebif), 0.25 mg SC every other day (Betaseron, Extavia); 44 mcg SC three times a week (Rebif) Pegylated interferon (Plegridy), 125 mcg SC every 14 days Teriflunomide (Aubagio), 14 mg orally (PO) daily Dimethyl fumarate (Tecfidera and generics), 240 mg PO twice a day Diroximel fumarate (Vumerity), 462 mg PO twice a day Monomethyl fumarate (Bafiertam), 190 mg PO twice a day Fingolimod (Gilenya and generics), 0.5 mg PO daily Siponimod (Mayzent), 1 mg PO daily or 2 mg PO daily Ozanimod (Zeposia), 0.92 mg PO daily Ponesimod (Ponvory), 20 mg PO daily
Group II: Early Aggressive TherapyActive Control1 Intervention
Higher efficacy disease-modifying therapy (Early Aggressive Therapy) for treatment of multiple sclerosis Early Aggressive Therapy choices and maximum allowable doses: Natalizumab (Tysabri), 300 mg intravenously (IV) every 4 weeks Alemtuzumab (Lemtrada), 12 mg IV daily for 5 days; 1 year later: 12 mg IV daily for 3 days Ocrelizumab (Ocrevus), 300 mg IV every 2 weeks (for 2 doses) at initiation; subsequently, 600 mg IV every 6 months Rituximab (Rituxan), 1000 mg IV every 2 weeks (for 2 doses); may repeat every 16-24 weeks Cladribine (Mavenclad), 3.5 mg per kg body weight PO divided into 2 yearly treatment courses (1.75 mg per kg body weight each year); each yearly treatment course is divided into 2 treatment cycles; administer cycle dosage as 1 or 2 tablets once daily over 4-5 consecutive days Ofatumumab (Kesimpta), 20 mg SC weekly for weeks 0, 1 and 2; 20 mg SC monthly starting at week 4

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,285 Previous Clinical Trials
14,842,165 Total Patients Enrolled
30 Trials studying Multiple Sclerosis
1,668 Patients Enrolled for Multiple Sclerosis
Patient-Centered Outcomes Research InstituteOTHER
563 Previous Clinical Trials
29,991,250 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
26,392 Patients Enrolled for Multiple Sclerosis
Ellen M. Mowry, MD, MCRPrincipal InvestigatorJohns Hopkins University

Media Library

Early Aggressive Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03500328 — N/A
Multiple Sclerosis Research Study Groups: Traditional Therapy, Early Aggressive Therapy
Multiple Sclerosis Clinical Trial 2023: Early Aggressive Therapy Highlights & Side Effects. Trial Name: NCT03500328 — N/A
Early Aggressive Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03500328 — N/A
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT03500328 — N/A
~126 spots leftby Aug 2025
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