DELIVER-MS Biorepository

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.