Back to resultsDetermining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (DELIVER-MS)
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Early Highly Effective Therapies Group
Escalation Therapies Group
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 18 to 60 years.
- Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria (99).
- RRMS disease course as defined by the 2013 revisions of the MS clinical course definition (4).
- Participants must have evidence of active disease based on: one or more MS relapses within the last 18 months prior to screening visit or radiological evidence of MS activity (≥2 new T2 lesions within the last 12 months from screening [compared to a previous recent MRI within 18 months of screening] or ≥1 GdE demonstrated on brain or spinal cord MRI performed within the last 12 months of screening).
- Participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve (i.e., no MS DMT at any time in the past).
- Participants must be eligible to receive at least one form of DMT within each treatment arm.
- EDSS at Baseline visit ≤ 6.5
Exclusion Criteria:
- Participants with contraindications to all forms of DMT in either of the treatment arms.
- Participants must never have received any of the following medications: natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine, siponimod, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, daclizumab, mitoxantrone, diroximel fumarate, ozanimod, monomethyl fumarate, ponesimod.
- Participants must have not received any of the following medications, for reasons other than MS, in the last 12 months: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, leflunomide, laquinimod, atacicept, other monoclonal antibodies.
- Participants with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study
- Participants unable to provide informed consent.
- Contraindication or inability to undergo MRI with Gd due to metal or metal implants, allergy to Gd contrast, claustrophobia, pain, spasticity, or excessive movement related to tremor.
- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the PI, is likely to affect the participant's ability to comply with the study protocol.
Sites / Locations
- University of Colorado-Anschutz Medical CampusRecruiting
- University of MinnesotaRecruiting
- Mayo ClinicRecruiting
- Cleveland Clinic Lou Ruvo Center for Brain HealthRecruiting
- University of BuffaloRecruiting
- University Rochester Medical CenterRecruiting
- University of CincinnatiRecruiting
- Cleveland ClinicRecruiting
- Ohio HealthRecruiting
- UT-AustinRecruiting
- Baylor College of Medicine, HoustonRecruiting
- UTHealth-HoustonRecruiting
- University of VirginiaRecruiting
- Virginia Commonwealth UniversityRecruiting
- University of Wisconsin-MadisonRecruiting
- University Hospitals Coventry and WarwickshireRecruiting
- Frimley Park
- The Leeds Teaching Hospitals NHS Trust, Leeds General InfirmaryRecruiting
- University Hospitals LeicesterRecruiting
- Imperial College Healthcare NHS Trust, Charing Cross HospitalRecruiting
- University College London Hospitals NHS Foundation Trust, University College HospitalRecruiting
- Salford Royal NHS Foundation Trust, Salford HospitalRecruiting
- Oxford University Hospitals NHS Foundation Trust, John Radcliffe HospitalRecruiting
- University Hospitals Plymouth NHS Trust, Derriford HospitalRecruiting
- Sheffield Teaching HospitalsRecruiting
- University Hospitals of North MidlandsRecruiting
- Royal Infirmary of EdinburghRecruiting
- Cardiff and Vale University Local Health Board, University Hospital of WalesRecruiting
- Aneurin Bevan Local Health Board Headquarters, Royal Gwent HospitalRecruiting
- Swansea Bay University Local Health Board, Morriston HospitalRecruiting
- Nottingham University Hospitals NHS Trust, Queens Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
EHT: Early Highly-effective
ESC: Escalation
OBS: Observational
Arm Description
Participants randomized to the "EHT: Early Highly-effective" arm will receive one of the highly effective MS therapies (Ocrevus, Lemtrada, Tysabri, Rituximab, Kesimpta) as their initial disease modifying treatment. Interventions: one of the highly effective MS therapies The randomization affects only the INITIAL treatment received. Once that treatment has been initiated, any subsequent changes are made according to standard clinical practice, regardless of randomization group.
Participants randomized to the "ESC: Escalation" arm will receive any other approved MS therapy (not one of the EHT group) as their initial disease modifying treatment. Interventions: one of the MS therapies NOT in the highly effective group The randomization affects only the INITIAL treatment received. Once that treatment has been initiated, any subsequent changes are made according to standard clinical practice, regardless of randomization group.
Participants will not be restricted to a group of MS therapies. Participants enter this arm if they are not comfortable with randomization, are not eligible to receive any of the options in a randomized arm, or are not able to secure insurance coverage for any therapy in a randomized arm.
Outcomes
Primary Outcome Measures
Brain volume loss, baseline to month 36
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.
EDSS+, month 48 to month 72
To determine whether an EHT approach to DMT, defined as use of one of six monoclonal antibodies (alemtuzumab, natalizumab, rituximab, ocrelizumab, ofatumumab, ublituximab) as first-line therapy, is more effective than an escalation of treatment approach in reducing time to reach a multidimensional composite comprised of EDSS+ worsening. EDSS+ worsening will be defined as worsening on ⩾ 1 of the 3 components: EDSS, 9HPT, or T25FW, which is confirmed at another visit after 12 months. EDSS worsening will be defined as a ⩾1.0-point increase from a baseline score of ⩽5.5 or a ⩾0.5-point increase from a baseline score of ⩾6.0. T25FW and 9HPT worsening will be defined as ⩾20% worsening from baseline.
Secondary Outcome Measures
Brain volume loss, month 6 to month 36
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 Month 6 to Month 36.
Proportion of participants with progression
Proportion of participants with a multidimensional composite comprised of EDSS progression (>1.5 points for those with EDSS of 0 at Baseline, ≥1.0 for those with EDSS of 0.5-5.0 at Baseline, and >0.5 points for those with EDSS above 5.0 at Baseline), 20% change in MSFC-4 subcomponents (T25FW, 9HPT), 10% in SDMT or, 1 line change in LCLA confirmed over 12 months.
Change in MSIS-29, baseline to 36 months
Change in MSIS-29 responses from participants
Change in Neuro-QOL, baseline to 36 months
11 subscales, each is scored separately, there is no composite score
Physical Domains:
Upper Extremity Function (Fine Motor, ADL):
Higher scores indicate: Better Functioning
Lower Extremity Function (Mobility):
Higher scores indicate: Better Functioning
Fatigue:
Higher scores indicate: Worse Functioning
Sleep Disturbance:
Higher scores indicate: Worse Functioning
Mental Domains:
Cognition Function:
Higher scores indicate: Better Functioning
Stigma:
Higher scores indicate: Worse Functioning
Anxiety:
Higher scores indicate: Worse Functioning
Depression:
Higher scores indicate: Worse Functioning
Positive Affect and Well -being:
Higher scores indicate: Better Functioning
Social Domains:
Ability to Participate in Social Roles and Activities:
Higher scores indicate: Better Functioning
Satisfaction with Social Roles and Activities:
Higher scores indicate: Better Functioning
Time to reach SPMS, month 48 to month 72
To determine the efficacy of an EHT approach as compared to an escalation approach as reflected by the following:
Time to reach secondary progressive MS (SPMS) as defined by worsening on the EDSS (3 strata definition for EDSS worsening plus EDSS score of ≥4 and pyramidal score ≥2), confirmed at 12 months, over 72 months
Proportion of participants with a 20% or greater change in T25FW at 72 months.
Proportion of participants with a 20% or greater change in 9HPT at 72 months.
Proportion of participants with a 20% or greater change in the SDMT at 72 months.
Efficacy difference between EHT and ESC, month 48 to month 72
To determine the efficacy of an EHT approach as compared to an escalation approach as reflected in the following patient-reported outcomes:
The change in participant-perceived symptoms as measured by the MSIS-29.
The change in participant quality of life as measured by Neuro-QOL.
Safety difference between EHT and ESC, month 48 to month 72
To determine the safety of an EHT approach as compared to an escalation approach as reflected in the following:
Proportion of participants with SAEs
Rate of SAEs
Proportion of participants with DMT discontinuation due to safety or tolerability concerns
Cumulative on-therapy TSQM Response scores
Full Information
NCT ID
NCT03535298
First Posted
May 14, 2018
Last Updated
August 14, 2023
Sponsor
The Cleveland Clinic
Collaborators
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT03535298
Brief Title
Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS
Acronym
DELIVER-MS
Official Title
Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
April 30, 2030 (Anticipated)
Study Completion Date
September 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EHT: Early Highly-effective
Arm Type
Experimental
Arm Description
Participants randomized to the "EHT: Early Highly-effective" arm will receive one of the highly effective MS therapies (Ocrevus, Lemtrada, Tysabri, Rituximab, Kesimpta) as their initial disease modifying treatment.
Interventions: one of the highly effective MS therapies
The randomization affects only the INITIAL treatment received. Once that treatment has been initiated, any subsequent changes are made according to standard clinical practice, regardless of randomization group.
Arm Title
ESC: Escalation
Arm Type
Experimental
Arm Description
Participants randomized to the "ESC: Escalation" arm will receive any other approved MS therapy (not one of the EHT group) as their initial disease modifying treatment.
Interventions: one of the MS therapies NOT in the highly effective group
The randomization affects only the INITIAL treatment received. Once that treatment has been initiated, any subsequent changes are made according to standard clinical practice, regardless of randomization group.
Arm Title
OBS: Observational
Arm Type
No Intervention
Arm Description
Participants will not be restricted to a group of MS therapies.
Participants enter this arm if they are not comfortable with randomization, are not eligible to receive any of the options in a randomized arm, or are not able to secure insurance coverage for any therapy in a randomized arm.
Intervention Type
Drug
Intervention Name(s)
Early Highly Effective Therapies Group
Other Intervention Name(s)
Lemtrada (alemtuzumab), Ocrevus (ocrelizumab), Tysabri (natalizumab), Rituxan (rituximab), Kesimpta (ofatumumab), Briumvi (ublituximab)
Intervention Description
Highly Effective MS Therapy group of medications
Intervention Type
Drug
Intervention Name(s)
Escalation Therapies Group
Other Intervention Name(s)
Betaseron (beta interferon), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Extavia (beta interferon), Gilenya (fingolimod), Glatopa (glatiramer acetate), Plegridy (beta interferon), Rebif (beta interferon), Tecfidera (dimethyl fumarate), Avonex (beta interferon), Mavenclad (cladribine), Mayzent (siponimod), Vumerity (diroximel fumarate), Zeposia (ozanimod), Bafiertam (monomethyl fumarate), Ponvory (ponesimod)
Intervention Description
Escalation MS Therapy group of medications
Primary Outcome Measure Information:
Title
Brain volume loss, baseline to month 36
Description
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.
Time Frame
Baseline to 36 months
Title
EDSS+, month 48 to month 72
Description
To determine whether an EHT approach to DMT, defined as use of one of six monoclonal antibodies (alemtuzumab, natalizumab, rituximab, ocrelizumab, ofatumumab, ublituximab) as first-line therapy, is more effective than an escalation of treatment approach in reducing time to reach a multidimensional composite comprised of EDSS+ worsening. EDSS+ worsening will be defined as worsening on ⩾ 1 of the 3 components: EDSS, 9HPT, or T25FW, which is confirmed at another visit after 12 months. EDSS worsening will be defined as a ⩾1.0-point increase from a baseline score of ⩽5.5 or a ⩾0.5-point increase from a baseline score of ⩾6.0. T25FW and 9HPT worsening will be defined as ⩾20% worsening from baseline.
Time Frame
48 months to 72 months
Secondary Outcome Measure Information:
Title
Brain volume loss, month 6 to month 36
Description
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 Month 6 to Month 36.
Time Frame
Month 6 to month 36
Title
Proportion of participants with progression
Description
Proportion of participants with a multidimensional composite comprised of EDSS progression (>1.5 points for those with EDSS of 0 at Baseline, ≥1.0 for those with EDSS of 0.5-5.0 at Baseline, and >0.5 points for those with EDSS above 5.0 at Baseline), 20% change in MSFC-4 subcomponents (T25FW, 9HPT), 10% in SDMT or, 1 line change in LCLA confirmed over 12 months.
Time Frame
Baseline to 36 months
Title
Change in MSIS-29, baseline to 36 months
Description
Change in MSIS-29 responses from participants
Time Frame
Baseline to 36 months
Title
Change in Neuro-QOL, baseline to 36 months
Description
11 subscales, each is scored separately, there is no composite score
Physical Domains:
Upper Extremity Function (Fine Motor, ADL):
Higher scores indicate: Better Functioning
Lower Extremity Function (Mobility):
Higher scores indicate: Better Functioning
Fatigue:
Higher scores indicate: Worse Functioning
Sleep Disturbance:
Higher scores indicate: Worse Functioning
Mental Domains:
Cognition Function:
Higher scores indicate: Better Functioning
Stigma:
Higher scores indicate: Worse Functioning
Anxiety:
Higher scores indicate: Worse Functioning
Depression:
Higher scores indicate: Worse Functioning
Positive Affect and Well -being:
Higher scores indicate: Better Functioning
Social Domains:
Ability to Participate in Social Roles and Activities:
Higher scores indicate: Better Functioning
Satisfaction with Social Roles and Activities:
Higher scores indicate: Better Functioning
Time Frame
Baseline to 36 months
Title
Time to reach SPMS, month 48 to month 72
Description
To determine the efficacy of an EHT approach as compared to an escalation approach as reflected by the following:
Time to reach secondary progressive MS (SPMS) as defined by worsening on the EDSS (3 strata definition for EDSS worsening plus EDSS score of ≥4 and pyramidal score ≥2), confirmed at 12 months, over 72 months
Proportion of participants with a 20% or greater change in T25FW at 72 months.
Proportion of participants with a 20% or greater change in 9HPT at 72 months.
Proportion of participants with a 20% or greater change in the SDMT at 72 months.
Time Frame
48 months to 72 months
Title
Efficacy difference between EHT and ESC, month 48 to month 72
Description
To determine the efficacy of an EHT approach as compared to an escalation approach as reflected in the following patient-reported outcomes:
The change in participant-perceived symptoms as measured by the MSIS-29.
The change in participant quality of life as measured by Neuro-QOL.
Time Frame
48 months to 72 months
Title
Safety difference between EHT and ESC, month 48 to month 72
Description
To determine the safety of an EHT approach as compared to an escalation approach as reflected in the following:
Proportion of participants with SAEs
Rate of SAEs
Proportion of participants with DMT discontinuation due to safety or tolerability concerns
Cumulative on-therapy TSQM Response scores
Time Frame
48 months to 72 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women aged 18 to 60 years.
Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria (99).
RRMS disease course as defined by the 2013 revisions of the MS clinical course definition (4).
Participants must have evidence of active disease based on: one or more MS relapses within the last 18 months prior to screening visit or radiological evidence of MS activity (≥2 new T2 lesions within the last 12 months from screening [compared to a previous recent MRI within 18 months of screening] or ≥1 GdE demonstrated on brain or spinal cord MRI performed within the last 12 months of screening).
Participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve (i.e., no MS DMT at any time in the past).
Participants must be eligible to receive at least one form of DMT within each treatment arm.
EDSS at Baseline visit ≤ 6.5
Exclusion Criteria:
Participants with contraindications to all forms of DMT in either of the treatment arms.
Participants must never have received any of the following medications: natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine, siponimod, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, daclizumab, mitoxantrone, diroximel fumarate, ozanimod, monomethyl fumarate, ponesimod.
Participants must have not received any of the following medications, for reasons other than MS, in the last 12 months: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, leflunomide, laquinimod, atacicept, other monoclonal antibodies.
Participants with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study
Participants unable to provide informed consent.
Contraindication or inability to undergo MRI with Gd due to metal or metal implants, allergy to Gd contrast, claustrophobia, pain, spasticity, or excessive movement related to tremor.
Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the PI, is likely to affect the participant's ability to comply with the study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Planchon Pope, PhD
Phone
216-636-1232
Email
planchs@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Ontaneda, MD, MSc
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nikos Evangelou, MD, DPhil
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado-Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donavaughn Baucom
Phone
303-724-0797
Email
DONAVAUGHN.BAUCOM@CUANSCHUTZ.EDU
First Name & Middle Initial & Last Name & Degree
Enrique. Alvarez,, MD,PhD
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Zander
Phone
612-624-6778
Email
zande001@umn.edu
First Name & Middle Initial & Last Name & Degree
William Schmalsteig, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Bush
Email
Bush.Melissa1@mayo.edu
First Name & Middle Initial & Last Name & Degree
Orhun Kantarci
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Suazo
Phone
702-701-7972
Email
suazoj@ccf.org
First Name & Middle Initial & Last Name & Degree
Carrie Hersh, DO, MSc
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Patrick
Phone
716-829-5037
Email
kpatrick@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Bianca Weinstock-Guttman, MD
Facility Name
University Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Sauvain
Phone
585-273-3688
Email
Jean_Sauvain@URMC.Rochester.edu
First Name & Middle Initial & Last Name & Degree
Megan Hyland, MD
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gideon Gyebi
Phone
513-558-2248
Email
gyebign@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Aram Zabeti, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhonda Jones
Phone
216-445-9855
Email
jonesr42@ccf.org
First Name & Middle Initial & Last Name & Degree
Daniel Ontaneda, MD, PhD
Facility Name
Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sadio Abdul
Phone
614-566-9510
Email
sadio.abdul@OhioHealth.com
First Name & Middle Initial & Last Name & Degree
Jacqueline A Nicholas, MD, MPH
Facility Name
UT-Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Huson
Email
ethan.huson@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Leorah Freeman
Facility Name
Baylor College of Medicine, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tahari Griffin
Phone
713-798-6097
Email
tgriffin@bcm.edu
First Name & Middle Initial & Last Name & Degree
George Hutton, MD
Facility Name
UTHealth-Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James (Jim) Jemelka
Phone
713-500-7045
Email
James.r.jemelka@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Rajesh Gupta, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Keller
Phone
434-243-5457
Email
mfk8e@virginia.edu
First Name & Middle Initial & Last Name & Degree
Mini Singh, MD
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karina Vences
Phone
804-852-4216
Email
venceskm@vcu.edu
First Name & Middle Initial & Last Name & Degree
Myla Goldman, MD
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Janko
Phone
608-262-8027
Email
janko@neurology.wisc.edu
First Name & Middle Initial & Last Name & Degree
Natasha Frost, MD
Facility Name
University Hospitals Coventry and Warwickshire
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Wild
Email
Laura.wild3@uhcw.nhs.uk
First Name & Middle Initial & Last Name & Degree
Tarunya Arun
Facility Name
Frimley Park
City
Frimley
State/Province
England
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Craner
Facility Name
The Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary
City
Leeds
State/Province
England
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanaz Begum
Phone
+44 0113 3926230
Email
shanaz.begum9@nhs.net
First Name & Middle Initial & Last Name & Degree
Oliver Lily, MD
Facility Name
University Hospitals Leicester
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehanah Roopun
Email
rehanah.roopun@uhl-tr.nhs.uk
First Name & Middle Initial & Last Name & Degree
Maz Matar
Facility Name
Imperial College Healthcare NHS Trust, Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Cerri
Phone
+44 020 8 383 0675
Email
a.cerri@nhs.net
First Name & Middle Initial & Last Name & Degree
Richard Nicholas, MD
Facility Name
University College London Hospitals NHS Foundation Trust, University College Hospital
City
London
State/Province
England
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iwona Pisarek
Phone
+44 07984464615
Email
iwona.pisarek@nhs.net
First Name & Middle Initial & Last Name & Degree
Wallace Brownlee, MD
Facility Name
Salford Royal NHS Foundation Trust, Salford Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Brooke
Phone
+44 0161 206 1829
Email
Judith.Brooke@srft.nhs.uk
First Name & Middle Initial & Last Name & Degree
David Rog, MD
Facility Name
Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Cavey
Phone
+44 01865 231869
Email
ana.cavey@ndcn.ox.ac.uk
First Name & Middle Initial & Last Name & Degree
Matthew Craner, MD
Facility Name
University Hospitals Plymouth NHS Trust, Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henry Redmond-Harrison
Phone
+44 01752 431247
Email
h.harrison-redmond@nhs.net
First Name & Middle Initial & Last Name & Degree
Jeremy Hobart, MD
Facility Name
Sheffield Teaching Hospitals
City
Sheffield
State/Province
England
ZIP/Postal Code
S5 7AT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Buckley
Email
lauren.buckley@nbt.nhs.uk
First Name & Middle Initial & Last Name & Degree
David Paling
Facility Name
University Hospitals of North Midlands
City
Stoke
State/Province
England
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ukraina Garcia
Email
Ukraina.garcia@uhnm.nhs.uk
First Name & Middle Initial & Last Name & Degree
Seema Karla
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanya Van der Westhuizen
Email
tvander@exseed.ac.uk
First Name & Middle Initial & Last Name & Degree
Don Mahad
Facility Name
Cardiff and Vale University Local Health Board, University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Butcher
Phone
+44 2920 746394
Email
Cynthia.butcher@wales.nhs.uk
First Name & Middle Initial & Last Name & Degree
Emma Tallantyre, MD
Facility Name
Aneurin Bevan Local Health Board Headquarters, Royal Gwent Hospital
City
Newport
State/Province
Wales
ZIP/Postal Code
NP19 0BH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Williams
Email
sarah.H.williams@wales.nhs.uk
First Name & Middle Initial & Last Name & Degree
Fady Joseph, ND
Facility Name
Swansea Bay University Local Health Board, Morriston Hospital
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbie Williams
Phone
+44 01792 703722
Email
Debbie.williams8@wales.nhs.uk
First Name & Middle Initial & Last Name & Degree
Owen Pearson, MD
Facility Name
Nottingham University Hospitals NHS Trust, Queens Medical Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Stone
Phone
+44 115 9249924
Ext
66816
Email
charlotte.stone3@nuh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Nikos Evangelou, MD, DPhil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS
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