Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Best Available Therapy (BAT) for Relapsing Multiple Sclerosis

This is a multi-center prospective rater-masked (blinded) randomly assigned 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). you would be randomly assigned at a 1 to 1 (1:1) ratio.

Official registry: https://clinicaltrials.gov/study/NCT04047628 · National Institute of Allergy and Infectious Diseases (NIAID) · enrollment listed as 156

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Autologous Hematopoietic Stem Cell Transplantation, or Best Available Therapy (BAT). The registry lists allocation as randomized. This is a multi-center prospective rater-masked (blinded) randomly assigned 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).

They plan to enroll about 156 people at 23 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)

Interventions: Autologous Hematopoietic Stem Cell Transplantation, Best Available Therapy (BAT)

Primary outcome (registry wording): Multiple Sclerosis (MS) Relapse-Free Survival

Who it is for (from inclusion criteria)

  • Ages 18 Years to 55 Years
  • 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
  • At least one episode of disease activity must have occurred within the 12 months prior to the screening visit (Visit -2), and
  • 1\. A gadolinium-enhancing lesion, or 2. A new non-enhancing T2 lesion compared to a reference scan obtained not more than 36 months prior to the screening visit (Visit -2)
  • 6\. Candidacy for treatment with at least one of the following high how well it works BAT DMTs: cladribine, natalizumab, alemtuzumab, ocrelizumab, ofatumumab, ublituximab and rituximab. Candidacy for treatment for each BAT DMT is defined as meeting all of the following:

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

23 listed

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NCT00794352 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

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FAQ about this NCT record

Is NCT04047628 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04047628?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04047628?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary