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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 87 months after randomization

Awards & highlights

No Placebo-Only Group

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.

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.

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 day1 visit

Treatment ~ 84 months15 visits

Follow Up ~ from 6 months after starting 1st therapy up to 87 months after randomization

Screening ~ 1 day

Treatment ~ 84 months

Follow Up ~from 6 months after starting 1st therapy up to 87 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 87 months after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Overall Burden of MS

Time to sustained disability progression

Secondary study objectives

Adverse event resulting in a decision to change disease-modifying therapy

Cognition using Symbol Digit Modality Test (SDMT)

Employment status

+23 more

Other study objectives

Brain Magnetic Resonance Imaging (MRI) evidence of neurodegeneration

Brain

Pharmaceutical Preparations

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: 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 IV every 4 wks * Alemtuzumab (Lemtrada), 12 mg IV daily (QD) for 5 days; 1 year later: 12 mg IV QD for 3 days * Ocrelizumab (Ocrevus), 300 mg IV every 2 wks (for 2 doses) at initiation; then 600 mg IV every 6 mths * Rituximab (Rituxan), 1000 mg IV every 2 wks (for 2 doses); may repeat every 16-24 wks * Cladribine (Mavenclad), 3.5 mg per kg body weight orally divided into 2 yrly treatment courses (1.75 mg per kg body weight each year); each yrly treatment course is divided into 2 treatment cycles; administer cycle dosage as 1 or 2 tablets QD over 4-5 consecutive days * Ofatumumab (Kesimpta), 20 mg SC wkly for wks 0, 1 and 2; 20 mg subcutaneously (SC) monthly starting at wk 4 * Ublituximab-xiiy (Briumvi), 150 mg IV (first dose); 450 mg IV 2 wks after first dose; 450 mg IV q 24 wks

Group II: 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 SC daily, or 40 mg SC 3 times a wk * Intramuscular (IM) interferon (Avonex), 30 mcg IM weekly * SC interferon (Betaseron, Extavia, Rebif), 0.25 mg SC every other day (Betaseron, Extavia); 44 mcg SC 3 times a wk (Rebif) * Pegylated interferon (Plegridy), 125 mcg SC every 14 days * Teriflunomide (Aubagio), 14 mg PO QD * Dimethyl fumarate (Tecfidera and generics), 240 mg PO twice a day (BID) * Diroximel fumarate (Vumerity), 462 mg PO BID * Monomethyl fumarate (Bafiertam), 190 mg PO BID * Fingolimod (Gilenya and generics), 0.5 mg PO QD * Siponimod (Mayzent), 1 mg PO QD or 2 mg PO QD * Ozanimod (Zeposia), 0.92 mg PO QD * Ponesimod (Ponvory), 20 mg PO QD * Fingolimod ODT (Tascenso), 0.25 mg PO QD if \<=40 kg; 0.5 mg PO QD if \> 40 kg

0 / 5Eligibility criteria met