Clinical Trial

Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)

Study acronym: BEAT-MS
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).
Protocol Amendment History 51 amendments
This ClinicalTrials.gov record has been amended 51 times since 2019-08-05; most recent amendment 2026-01-02.
Status change: Not Yet Recruiting → Recruiting 2019-12-19
Trial Details
NCT Number NCT04047628
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Immune Tolerance Network (ITN), Blood and Marrow Transplant Clinical Trials Network, PPD Development, LP, Rho Federal Systems Division, Inc.
Conditions Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Enrollment 156 participants
Start Date 2019-12-19
Primary Completion 2026-10 (estimated)
Study Completion 2029-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-06