Documentation
Associated Media:
Description:
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.
Coverage
Spatial:
UK and USA
Typical Age Range:
18-55
Follow Up:
1 - 10 Years
Pathway:
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.
Provenance
Origin
Purposes:
- Research cohort
- Trial
- Care
- Study
Sources:
Other
Collection Situations:
- Cohort, study, trial
- Secondary care - Outpatients
Temporal
Accrual Periodicity:
Other
Distribution Release Date:
01 January 2027
Start Date:
30 November 2019
Time Lag:
Variable
Accessibility
Access
Access Rights:
In progress
Access Service:
in progress
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.
Delivery Lead Time:
Variable
Jurisdictions:
UK
Data Controller:
Cardiff University - UK Cleveland Clinic - USA
Data Processor:
Cardiff University - UK Cleveland Clinic - USA
Usage
Data Use Limitations:
Research-specific restrictions
Data Use Requirements:
- Project-specific restrictions
- Collaboration required
Resource Creators:
tbc
Format and Standards
Vocabulary Encoding Schemes:
LOCAL
Conforms To:
LOCAL
Languages:
en
Formats:
text
Observations
Statistical Population
Population Description
Population Size
Measured Property
Observation Date
Events
Number of DNA sample aliquots
456
sample aliquot
09 September 2025
Events
Number of serum sample aliquots
5626
sample aliquot
09 September 2025
Events
Number of total sample aliquots provided to date
12584
sample aliquot
09 September 2025
Events
Number of plasma sample aliquots
3554
sample aliquot
09 September 2025
Events
Number of PBMC sample aliquots
2948
sample aliquot
09 September 2025
Events
Number of participants initially commenced on Ublituximab
1
people
09 September 2025
Persons
Number of participants initially commenced on Ofatumumab
53
people
09 September 2025
Persons
Number of participants initially commenced on Siponimod
3
people
09 September 2025
Persons
Number of participants initially commenced on Teriflunomide
5
people
09 September 2025
Persons
Number of participants providing DNA samples
419
persons diagnosed with RRMS
09 September 2025
Persons
Number of participants initially commenced on Alemtuzumab
8
people
09 September 2025
Persons
Number of individuals enrolled into DELIVER-MS (UK) providing biorepository samples
234
persons diagnosed with RRMS
09 September 2025
Persons
Number of participants initially commenced on Peg-IFN beta 1a
12
people
09 September 2025
Persons
Number of participants providing plasma samples
232
persons diagnosed with RRMS
09 September 2025
Persons
Number of participants initially commenced on IFN Beta 1a
6
people
09 September 2025
Persons
Number of participants initially commenced on Ponesimod
4
people
09 September 2025
Persons
Number of participants initially commenced on Glatiramer Acetate
22
people
09 September 2025
Persons
Number of participants initially commenced on Rituximab
13
people
09 September 2025
Persons
Number of participants initially commenced on Natalizumab
36
people
09 September 2025
Persons
Number of participants initially commenced on Unknown DMT
16
people
09 September 2025
Persons
Number of participants initially commenced on Dimethyl Fumurate
67
people
09 September 2025
Persons
Number of participants providing serum samples
411
persons diagnosed with RRMS
09 September 2025
Persons
Number of participants initially commenced on Ozanimod
21
people
09 September 2025
Persons
Number of participants providing PBMC samples
448
persons diagnosed with RRMS
09 September 2025
Persons
Number of participants initially commenced on Ocreluzimab
178
people
09 September 2025
Persons
Number of participants initially commenced on Diroximol Fumurate
8
people
09 September 2025
Persons
Number of individuals enrolled into DELIVER-MS (UK and USA) providing biorepository samples
504
persons diagnosed with RRMS
10 September 2025
Persons
Number of individuals enrolled into DELIVER-MS (USA) providing biorepository samples
270
persons diagnosed with RRMS
09 September 2025
Persons
Number of participants initially commenced on Cladribine
34
people
09 September 2025
Persons
Number of participants initially commenced on Fingolimod
18
people
09 September 2025