Project Summary  

PCORI has identified multiple sclerosis (MS) as an important research topic. Patients, clinicians, and others want to learn how different treatment strategies, aimed at changing specific symptoms or the overall course of MS, affect patients’ symptoms and quality of life. To address this issue, PCORI launched an initiative in 2015 on Treatment of Multiple Sclerosis. The initiative funded this research project and others.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

MS is long-term health problem that affects more than 2.5 million people worldwide. It is a leading cause of disability among young adults in North America. Relapsing-remitting MS, or RRMS, is the most common type of MS. People with RRMS experience periods of worsening symptoms, called relapses, followed by periods of few or no symptoms, called remission.

There are two approaches for treating RMMS. With the first approach, called escalation, treatment starts with a medicine regarded as safe but that may not prevent all relapses or new brain lesions. If relapses or new lesions occur, clinicians prescribe stronger medicines that are better at preventing lesions and relapses, but which have a small chance of serious side effects such as infections. With the second approach, early treatment with highly effective medicine, treatment starts with one of the strong medicines.

This study is comparing the benefits and risks of starting treatment with an escalation approach versus an early highly effective treatment approach for patients with RMMS.

Who can this research help?

Patients with RMMS and their doctors can use findings from the study when considering a treatment approach.

What is the research team doing?

The team is working with treatment centers in the United States and the United Kingdom to recruit 800 patients with RMMS who have not yet had treatment for the disease. The team is assigning patients by chance to receive either escalation treatment or early highly effective treatment. Patients who want to be in the study but do not want treatment assigned by chance can decide on treatment with their clinicians.

For three years, the team is following up to find out how much patients’ brains shrink. The team also is studying patients’ thinking and memory, arm and leg movements, and eyesight. Patients are reporting their symptoms, quality of life, satisfaction with treatment, and side effects.

The team is comparing the two treatment approaches to understand how well each approach delays worsening of the disease. The team is also examining whether one approach is safer and easier for patients.

Research methods at a glance

Design Elements	Description
Design	Randomized controlled trial, observational study
Population	People with RMMS in the United States and United Kingdom who have not received treatment
Interventions/ Comparators	Escalation treatment Early highly effective treatment
Outcomes	Primary: brain volume loss from baseline to 36 months Secondary: brain volume loss from month 6 to month 36, patient reports of symptoms, quality of life, satisfaction with treatment, and side effects
Timeframe	3-year follow-up for primary outcome

Project Details

Principal Investigator

Daniel Ontaneda, MD

Other Principal Investigator

Nikolaos Evangelou, MD, DPhil

Project Status

In progress; Recruiting

Project Title

Determining the Effectiveness of Early Intensive versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis (DELIVER-MS)

Board Approval Date

September 2017

Project End Date

March 2024

Organization

Cleveland Clinic Foundation

Year Awarded

2017

State

Ohio

Project Type

Research Project

Health Conditions 

Mental/Behavioral Health

Functional Limitations and Disabilities

Neurological Disorders

Multiple Sclerosis

Funding Announcement

Treatment of Multiple Sclerosis

Project Budget

$10,626,363

Study Registration Information

HSRP20181653

NCT03535298