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NCT03535298 · ClinicalTrials.gov registry record · Phase 4
Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS
A Phase 4 study of Multiple Sclerosis (Relapsing Remitting), sponsored by The Cleveland Clinic.
- Active
- Registry status
- Phase 4
- Development phase
- 800
- Enrollment target
- 20
- Study locations
NCT03535298: Active Phase 4 study of Multiple Sclerosis (Relapsing Remitting), sponsored by The Cleveland Clinic.
NCT03535298 is a Phase 4 study of Multiple Sclerosis (Relapsing Remitting) that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 800 participants, above the 535-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03535298, a Phase 4 study of Multiple Sclerosis (Relapsing Remitting), is active but no longer recruiting, sponsored by The Cleveland Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 800 participants
- Enrollment target
- 20
- Study locations
Study Summary
The DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.
Primary Outcome
To determine whether an EHT approach to DMT, defined as use of one of four monoclonal antibodies (alemtuzumab, natalizumab, rituximab, or ocrelizumab) as first-line therapy, is more effective than an escalation of treatment approach in reducing normalized whole brain volume loss measured using MRI in PwRRMS from Baseline to Month 36.
Conditions Studied
Interventions
- DRUG Early Highly Effective Therapies Group
- DRUG Escalation Therapies Group
Study Locations (20)
England
- University Hospitals Coventry and Warwickshire - Coventry
- The Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary - Leeds
- University Hospitals Leicester - Leicester
- Imperial College Healthcare NHS Trust, Charing Cross Hospital - London
- University College London Hospitals NHS Foundation Trust, University College Hospital - London
Ohio
- University of Cincinnati - Cincinnati
- Cleveland Clinic - Cleveland
- Ohio Health - Columbus
Texas
- UT-Austin - Austin
- Baylor College of Medicine, Houston - Houston
- UTHealth-Houston - Houston
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester
New York
- University of Buffalo - Buffalo
- University Rochester Medical Center - Rochester
Virginia
- University of Virginia - Charlottesville
- Virginia Commonwealth University - Richmond
Colorado
- University of Colorado-Anschutz Medical Campus - Aurora
Nevada
- Cleveland Clinic Lou Ruvo Center for Brain Health - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2019-01-03 |
| Est. Completion | 2027-07-30 |
| Phase | Phase 4 |
What the registry record for NCT03535298 still lists
NCT03535298 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 535-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Multiple Sclerosis (Relapsing Remitting) appearing as the primary indexed condition, and to 2 interventions - of which Early Highly Effective Therapies Group is the first listed.
NCT03535298 names 20 study sites across 9 states, led by England, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT03535298 about?
NCT03535298 is a clinical study titled "Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS". The DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide...
What is the current status of trial NCT03535298?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 800 participants. The study started on 2019-01-03. Estimated completion is 2027-07-30.
What conditions does trial NCT03535298 study?
This clinical trial studies the following conditions: Multiple Sclerosis (Relapsing Remitting).
What interventions are being tested in trial NCT03535298?
The interventions under investigation include: Early Highly Effective Therapies Group (DRUG), Escalation Therapies Group (DRUG).
Who is sponsoring clinical trial NCT03535298?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03535298 being conducted?
This trial has 20 study locations across Colorado, Minnesota, Nevada, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis (Relapsing Remitting)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03535298's enrollment target sits among peer trials
800 6th of 29 higher than 24 of 29 other Multiple Sclerosis (Relapsing Remitting) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis (Relapsing Remitting) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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