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Compares treatment options for Relapsing Multiple Sclerosis
Official title Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
ClinicalTrials.gov ID: NCT04047628
What this study is testing
What is Best Available Therapy (BAT)?
Best Available Therapy (BAT) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsing multiple sclerosis.
Also referred to as natalizumab (Tysabri®), alemtuzumab (Campath®, Lemtrada®).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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...
- Highly active treatment-resistant relapsing MS, defined as ≥ 2 episodes of disease activity in the 36 months prior to the screening visit (Visit -2)...
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- At least one episode of disease activity must have occurred within the 12 months prior to the screening visit (Visit -2), and
- 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...
- No prior disease activity episode, as defined in Inclusion Criterion #5, with the candidate BAT DMT, and
- No contraindication to the candidate BAT DMT, and
- No treatment with the candidate BAT DMT in the 12 months prior to screening. 7\. Completion of COVID-19 vaccination series, according to the current Centers for Disease Control and Prevention (CDC) Advisory Committee on...
What rules you out
- 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).
- History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS).
- Presence of unexplained cytopenia, polycythemia, thrombocythemia or leukocytosis.
- History of sickle cell anemia or other hemoglobinopathy.
- Evidence of past or current hepatitis B or hepatitis C infection, including treated hepatitis B or hepatitis C. Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past...
- Presence or history of mild to severe cirrhosis.
- Hepatic disease with the presence of either of the following:
- Total bilirubin ≥ 1.5 times the upper limit of normal (ULN) or total bilirubin ≥ 3.0 times the ULN in the presence of Gilbert's syndrome, or
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2.0 times the ULN.
- Positive COVID-19 PCR test, or alternative nucleic acid amplification test (NAAT) per institutional standards, within 14 days prior to randomization (Day 0).
- Evidence of HIV infection.
- Positive QuantiFERON - TB Gold,TB Gold Plus, or T-SPOT®.TB test results. PPD tuberculin test may be substituted for QuantiFERON - TB Gold, TB Gold Plus, or T-SPOT®.TB test.
- Active viral, bacterial, endoparasitic, or opportunistic infections.
- Active invasive fungal infection.
- Hospitalization for treatment of infections or parenteral (IV or IM) antibacterials, antivirals, antifungals, or antiparasitic agents within the 30 days prior to randomization (Day 0) unless clearance is obtained from...
- Receipt of live or live-attenuated vaccines within 6 weeks of randomization (Day 0).
- Presence or history of clinically significant cardiac disease including: a. Arrhythmia requiring treatment with any antiarrhythmia therapy, with the exception of low dose beta blocker for intermittent premature...
- Left ventricular ejection fraction (LVEF) \< 50%.
- Impaired renal function defined as eGFR \< 60 mL/min/1.73 m2, according to the CKD-EPI formula144.
- Forced expiratory volume in one second (FEV1) \< 70% predicted (no bronchodilator).
- Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for Hgb) \< 70% predicted.
- Poorly controlled diabetes mellitus, defined as HbA1c \> 8%.
- History of malignancy, except adequately treated localized basal cell or squamous skin cancer, or carcinoma in situ of the cervix. Malignancies for which the participant is judged to be cured will be considered on an...
- Presence or history of any moderate to severe rheumatologic autoimmune disease requiring treatment, including but not limited to the following: systemic lupus erythematous, systemic sclerosis, rheumatoid arthritis...
- Presence of active peptic ulcer disease, defined as endoscopic or radiologic diagnosis of gastric or duodenal ulcer.
- Prior history of AHSCT.
- Prior history of solid organ transplantation.
- Positive pregnancy test or breastfeeding.
- Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
- Psychiatric illness, mental deficiency, or cognitive dysfunction severe enough to interfere with compliance or informed consent.
- History of hypersensitivity to rabbit or Escherichia coli-derived proteins.
- Any metallic material or electronic device in the body, or other condition that precludes the participant from undergoing MRI with gadolinium administration, as determined by the site radiologist.
- Presence or history of ischemic cerebrovascular disorders, including but not limited to transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage.
- Presence or history of other neurological disorders, including but not limited to CNS or spinal cord tumor; metabolic or infectious cause of myelopathy; genetically-inherited progressive CNS disorder; CNS sarcoidosis...
- Presence of any medical comorbidity that the investigator determines will significantly increase the risk of treatment mortality.
- Presence of any other concomitant medical condition that the investigator deems incompatible with trial participation.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Evanston, Illinois, United States
- Worcester, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Rochester, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Aurora, Colorado, United States; Evanston, Illinois, United States; Worcester, Massachusetts, United States; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.