Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosi… (NCT04047628) | Clinical Trial Compass
RecruitingPhase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
United States156 participantsStarted 2019-12-19
Plain-language 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).
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 18 to 55 years, inclusive, at the time of the screening Visit -2.
✓. Diagnosis of MS according to the 2017 McDonald Criteria139.
✓. EDSS ≤ 6.0 at the time of randomization (Day 0).
✓. T2 abnormalities on brain MRI that fulfill the 2017 McDonald MRI criteria for dissemination in space139. A detailed MRI report or MRI images must be available for review by the site neurology investigator.
✓. Highly active treatment-resistant relapsing MS, defined as ≥ 2 episodes of disease activity in the 36 months prior to the screening visit (Visit -2). The two disease activity episodes will be a clinical MS relapse or MRI evidence of MS disease activity and must meet all the criteria described below:
✓. At least one episode of disease activity must occur following ≥ 1 month of treatment with one of the following: (i) an oral DMT approved by the FDA for the treatment of relapsing MS, or (ii) a monoclonal antibody approved by the FDA for the treatment of relapsing MS, or (iii) rituximab. Qualifying DMTs include: dimethyl fumarate, diroximel fumarate, monomethyl fumarate, teriflunomide, cladribine, daclizumab, ponesimod, siponimod, ozanimod, fingolimod, rituximab, ocrelizumab, natalizumab, alemtuzumab, ublituximab, and ofatumumab, and
✓. At least one episode of disease activity must have occurred within the 12 months prior to the screening visit (Visit -2), and
What they're measuring
1
Multiple Sclerosis (MS) Relapse-Free Survival
Timeframe: From Day 0 (Randomization to Treatment) Up to 36 Months (3 Years)
Trial details
NCT IDNCT04047628
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✓. At least one episode of disease activity must be a clinical MS relapse (see item c.i. below). The other episode(s) must occur at least one month before or after the onset of the clinical MS relapse, and must be either another clinical MS relapse or MRI evidence of disease activity (see item c.ii. below):
Exclusion criteria
✕. Diagnosis of primary progressive MS according to the 2017 McDonald criteria.
✕. History of neuromyelitis optica spectrum disorder or MOG antibody disease.
✕. Prior treatment with an investigational agent within 3 months or 5 half-lives, whichever is longer. Agents authorized by the FDA for prevention or treatment of COVID-19 are not considered investigational.
✕. Either of the following within one month prior to randomization (Day 0):
✕. Onset of acute MS relapse, or
✕. Treatment with intravenous methylprednisolone 1000 mg/day for 3 days or equivalent.
✕. Initiation of any BAT DMT (see Section 5.2.1) between Visit -2 and randomization (Day 0).
✕. Brain MRI or cerebrospinal fluid (CSF) examination indicating a diagnosis of progressive multifocal leukoencephalopathy (PML).