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DELIVER-MS Biorepository

Population Size

504

People

Population Size statistic card

Years

2019

Years statistic card

Associated BioSamples

Serum

DNA

...see more

Associated BioSamples statistic card

Geographic coverage

UK and USA

Geographic coverage statistic card

Lead time

Variable

Lead time statistic card

Summary

Determining the Effectiveness of early Intensive Versus Escalation approaches for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). The DELIVER-MS study recruited people with RRMS who had not previously received any DMT. The study enrolled people who experienced their first symptoms within the prior 5 years to ensure they got the most benefit from immunomodulating DMTs, mirroring regular clinical practice. Samples were collected (Serum, Plasma, DNA, PBMCs) for biobanking.

Documentation

A biorepository of samples from individuals recruited to the DELIVER-MS clinical trial. Patients were followed in the DELIVER-MS study for a total of 3 years. Those in the randomized part of the study were told which initial DMT approach their neurologist would take, but their neurologist and the patient together were free to decide which medication within that approach to choose. Once a person with MS was enrolled in the study and commenced their first DMT, any subsequent changes that were required to the DMT were made at the discretion of their treating neurologist, in just the same way as in routine clinical settings. The aims of the study are to: i)Determine whether starting on a highly effective treatment is more effective than an escalation approach in slowing brain volume loss over 36 months ii) It will also assess which approach is more effective at improving patient reported outcomes (PRO) and clinical measures, and the safety and tolerability of each approach.

Biorepository Remit: Biomarkers that are predictive of a) long-term disability in MS and b) responses to disease-modifying therapy (whether a broad therapy response or a response to a specific therapy) are needed for people with MS. While new data suggest that several potential biomarkers may portend a worse long-term prognosis for MS, the interpretation of these results may be limited by the fact that the data were generated from either observational, non-randomized cohorts or from clinical trials in which patients who were chosen on the basis of a certain degree of recent disease activity. Hence, there is a need to evaluate such novel biomarkers in a prospective, less biased study in order to assess its true clinical applicability and generalizability. The DELIVER-MS trial, supported by PCORI and the NMSS, presents a unique opportunity for collection of biospecimens. The specific features making the biorepository include pragmatic design, broad inclusion criteria, of essentially newly-diagnosed, treatment-naïve patients, and their goals of long term follow-up. The collection of samples from study participants will be an optional activity.

Bio-samples were collected at 2 time points between Baseline and 36 month. Serum, Plasma and PBMCs isolated at both time points and DNA at a single time point only. Samples were split into aliquots and stored at -80 degrees for long term storage.

Dataset type

Treatments/Interventions, Health and disease

Dataset population size

504

Associated media

https://deliver-ms.com/

Keywords

Observations

Observed Node

Disambiguating Description

Measured Value

Measured Property

Observation Date

Persons

Number of individuals enrolled into DELIVER-MS (UK and USA) providing biorepository samples

504

persons diagnosed with RRMS

10 Sep 2025

Persons

Number of individuals enrolled into DELIVER-MS (UK) providing biorepository samples

234

persons diagnosed with RRMS

09 Sep 2025

Persons

Number of individuals enrolled into DELIVER-MS (USA) providing biorepository samples

270

persons diagnosed with RRMS

09 Sep 2025

Persons

Number of participants providing plasma samples

232

persons diagnosed with RRMS

09 Sep 2025

Persons

Number of participants providing serum samples

411

persons diagnosed with RRMS

09 Sep 2025

Persons

Number of participants providing DNA samples

419

persons diagnosed with RRMS

09 Sep 2025

Persons

Number of participants providing PBMC samples

448

persons diagnosed with RRMS

09 Sep 2025

Events

Number of plasma sample aliquots

3554

sample aliquot

09 Sep 2025

Events

Number of serum sample aliquots

5626

sample aliquot

09 Sep 2025

Events

Number of DNA sample aliquots

456

sample aliquot

09 Sep 2025

Events

Number of PBMC sample aliquots

2948

sample aliquot

09 Sep 2025

Events

Number of total sample aliquots provided to date

12584

sample aliquot

09 Sep 2025

Persons

Number of participants initially commenced on Alemtuzumab

8

people

09 Sep 2025

Persons

Number of participants initially commenced on Cladribine

34

people

09 Sep 2025

Persons

Number of participants initially commenced on Dimethyl Fumurate

67

people

09 Sep 2025

Persons

Number of participants initially commenced on Diroximol Fumurate

8

people

09 Sep 2025

Persons

Number of participants initially commenced on Fingolimod

18

people

09 Sep 2025

Persons

Number of participants initially commenced on Glatiramer Acetate

22

people

09 Sep 2025

Persons

Number of participants initially commenced on IFN Beta 1a

6

people

09 Sep 2025

Persons

Number of participants initially commenced on Natalizumab

36

people

09 Sep 2025

Persons

Number of participants initially commenced on Ocreluzimab

178

people

09 Sep 2025

Persons

Number of participants initially commenced on Ofatumumab

53

people

09 Sep 2025

Persons

Number of participants initially commenced on Ozanimod

21

people

09 Sep 2025

Persons

Number of participants initially commenced on Peg-IFN beta 1a

12

people

09 Sep 2025

Persons

Number of participants initially commenced on Ponesimod

4

people

09 Sep 2025

Persons

Number of participants initially commenced on Rituximab

13

people

09 Sep 2025

Persons

Number of participants initially commenced on Siponimod

3

people

09 Sep 2025

Persons

Number of participants initially commenced on Teriflunomide

5

people

09 Sep 2025

Events

Number of participants initially commenced on Ublituximab

1

people

09 Sep 2025

Persons

Number of participants initially commenced on Unknown DMT

16

people

09 Sep 2025

Provenance

Purpose of dataset collection

Research cohort, Trial, Care, Study

Source of data extraction

Other

Collection source setting

Cohort, study, trial, Secondary care - Outpatients

Patient pathway description

The DELIVER-MS study will recruit people with relapsing-remitting MS who have not previously received any DMT. The study is designed to reflect clinical practice in MS clinics. There is an age limit of 55 years given that most people are diagnosed with relapsing MS at a younger age. The study will enroll people who experienced their first symptoms within the last 5 years to ensure they will get the most benefit from immunomodulating DMTs, mirroring regular clinical practice. We will enroll a total of 400 people with MS into a randomized study, and a further 400 into an observational study.

Image contrast

Not stated

Biological sample availability

Serum,DNA,Peripheral blood cells,Plasma

Structural Metadata

Details

Publishing frequency

Other

Version

1.0.0

Modified

24/11/2025

Distribution release date

01/01/2027

Citation Requirements

tbc

Coverage

Start date

30/11/2019

Time lag

Variable

Geographic coverage

UK and USA

Minimum age range

18

Maximum age range

55

Follow-up

1 - 10 Years

Accessibility

Language

en

Alignment with standardised data models

LOCAL

Controlled vocabulary

LOCAL

Format

text

Data Access Request

Dataset pipeline status

Not available

Access rights

In progress

Time to dataset access

Variable

Access request cost

An indicative cost will be provided to applicants upon application. Charges will be based on workload associated with the application. Discussions surrounding costs to access material should be initiated prior to funding applications being made.

Access method category

Varies based on project

Access service description

in progress

Jurisdiction

UK

Data use limitation

Research-specific restrictions

Data use requirements

Project-specific restrictions,Collaboration required

Data Controller

Cardiff University - UK Cleveland Clinic - USA

Data Processor

Cardiff University - UK Cleveland Clinic - USA

Dataset Types: Treatments/Interventions, Health and disease

Dataset Sub-types: Therapeutic, Neurological

Collection Sources: Cohort, study, trial, Secondary care - Outpatients