Active not recruitingPHASE4INTERVENTIONAL

Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS

This study, called DELIVER-MS, wants to find out if giving powerful treatments for Multiple Sclerosis (MS) right from the beginning works better than starting with gentler medicines and only increasing strength if needed. Currently, doctors and patients don't have clear information to guide this important decision. The results of this study will help shape how MS treatments are approached in the future, not just for existing medications but also for new ones. This means it could make a big difference in how patients and their doctors choose treatments and could also help with decisions about approving new medicines.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

The Cleveland Clinic

Enrolment target

800

Start

03 Jan 2019

Estimated completion

30 Jul 2027

Multiple Sclerosis, Relapsing-Remitting

What is this study about?

The DELIVER-MS study is exploring a very important question for people with a type of MS called relapsing-remitting MS (RRMS). This is the most common form of MS, where people experience periods of new or worsening symptoms (relapses) followed by recovery. The main idea behind the study is to see if starting treatment with a strong medication early on can lead to better long-term results compared to a more gradual approach. The 'escalation' approach means starting with a milder treatment and only moving to stronger ones if the MS isn't well controlled.

Currently, there's no clear answer on which approach is best. Doctors and patients often have to make this decision without strong evidence to guide them. The study aims to fill this gap in knowledge. By comparing these two treatment strategies, the researchers hope to provide valuable information that can help people with MS and their healthcare teams make more informed choices about their treatment plan from the very start.

The findings from this study won't just apply to the treatments being used in the research; they could influence how doctors think about all MS treatments, including those not yet available. This means the study could have a wide-reaching impact on how MS is managed and could help ensure patients receive the most effective treatment for their condition.

Key takeaways

This study compares two main ways of treating new relapsing-remitting MS: starting strong or starting mild.
No one knows for sure which approach is best, and this study aims to find out.
The results could help many MS patients and doctors choose treatments in the future.
It's for people aged 18-60 with a recent MS diagnosis and no prior MS treatment.
Participation involves regular clinic visits, MRI scans, and taking study medication.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, participants need to be between 18 and 60 years old and have a confirmed diagnosis of relapsing-remitting MS. Your MS must have been diagnosed fairly recently (within the last five years) and you should not have received any MS treatment before. Also, your MS needs to show some recent activity, which means you've either had a relapse in the last year and a half or recent scans show new changes in your brain or spinal cord. You should also be able to walk without major difficulty.

There are also some reasons why you wouldn't be able to join. For example, if you have other serious health conditions that might make it unsafe for you to participate, or if you can't have an MRI scan (for example, due to metal implants). Also, if you've ever taken certain strong MS medications or if you've taken specific other medications for different reasons in the last year, you might not be eligible. The study team will check all these details carefully to make sure it's safe and appropriate for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old?
Have you been diagnosed with relapsing-remitting MS within the last five years?
Have you *never* taken any MS medication before?
Have you had a recent MS relapse or new changes on a recent MRI scan?
Can you walk without significant help?
Do you have any metal in your body that would prevent an MRI scan?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be assigned to one of two groups: one receiving early strong treatments, and the other starting with milder treatments that could be increased later. You will have regular visits to the clinic for assessments, which will include examinations, questionnaires, and blood tests. You will also have MRI scans of your brain and spinal cord periodically to check on your MS. The study involves taking the assigned medication regularly. The total duration of your participation in the study is not specified here, but it will involve ongoing follow-up for a significant period to track your MS progress and treatment effects.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of receiving what might be the most effective treatment approach for your MS, which could lead to better outcomes. However, as with any medical study, there are potential risks, such as side effects from the medications used. There is also the chance that the treatment approach you receive might not be more effective for you individually. You are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (30)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Colorado-Anschutz Medical Campus
Verified postcode
Aurora, United States
University of Minnesota
Verified postcode
Minneapolis, United States
Mayo Clinic
Verified postcode
Rochester, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Verified postcode
Las Vegas, United States
University of Buffalo
Verified postcode
Buffalo, United States
University Rochester Medical Center
Verified postcode
Rochester, United States
University of Cincinnati
Verified postcode
Cincinnati, United States
Cleveland Clinic
Verified postcode
Cleveland, United States
Ohio Health
Verified postcode
Columbus, United States
UT-Austin
Verified postcode
Austin, United States
Baylor College of Medicine, Houston
Verified postcode
Houston, United States
UTHealth-Houston
Verified postcode
Houston, United States

Common questions

What is relapsing-remitting MS?

It's the most common type of MS where symptoms come and go. Periods of new or worsening symptoms (relapses) are followed by recovery.

What does 'early highly effective therapies' mean?

It means starting with powerful MS medications soon after diagnosis, aiming to control the disease aggressively from the beginning.

What does 'escalation therapies' mean?

This approach starts with milder MS medications. If your MS symptoms or scans show it's not well controlled, then you'd switch to stronger treatments.

Will I know which treatment group I'm in?

The information provided doesn't specify if you will know your group, but this would be explained fully by the study team.

Who is funding this study?

The information provided does not state who is funding the study.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.