Status unknownRelapsing and progressiveNCT04674280

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • aHSCT

What it measured

Main measures

  • Time to NEDA-3 failure

    4 years

    Disability progressionRelapsesMRI lesions

Other measures (2)

  • Overall survival

    4 years

  • Transplant related mortality

    4 years

    Relapses

Who could take part

Relapsing and progressive · 18 to 65

Inclusion Criteria: * Diagnosis of MS according to McDonald's criteria * Availability of a detailed clinical history about MS, including progression of disability and relapse rate in the previous 2 years, treatments administered before aHSCT, and categorization of the sub-types of MS according to current EBMT guidelines * Highly active relapsing remitting MS failing DMTs * Progressive MS with active inflammatory component. In accordance with the EBMT guidelines, this category includes both secondary and primary progressive MS with active inflammatory component. * Aggressive (malignant) MS not previously treated with a full course of DMT * Patients aged 18 or over at time of first aHSCT * Signed informed consent Exclusion Criteria: * Lack of one of the above criteria * Progressive MS without active inflammatory component, as this indication is assigned 'GNR' according to EBMT guidelines, irrespective of whether it is secondary or primary progressive. * Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient be able to return for the scheduled follow-up visits. * Patients with cognitive impairments, who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are considered part of routine patient care.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Observational prospective , multi-center study Primary objective : To gain further homogenous evidence for clinical efficacy of aHSCT in patients undergoing aHSCT for MS as primary indication. Secondary objectives: * Safety, tolerability and toxicity of aHSCT in MS * Quality of life and long-term disability after aHSCT * MRI outcome after aHSCT Primary endpoint : Time to failure to maintain a NEDA status Secondary endpoints: * Overall survival * Transplant related mortality * MRI Assessment including lesions * Treatment-related complications . • Quality of life through the MS QL 54 standard assessment * Improvement of disability Inclusion criteria: * Diagnosis of MS according to the 2010 revision McDonald's criteria * Availability of a detailed clinical history about MS, including progression of disability and relapse rate in the previous 2 years, previous treatments administered * Patients aged 18yrs or over at the time of the first aHSCT Exclusion criteria: * Lack of one of the above criteria * Physical, mental, or social condition which could affect the patient from returning for follow-up visits * Patients with cognitive impairments, who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are considered part of routine patient care. Recruitment: 50 patients Recruitment period: 2 years starting from the inclusion of the 1st patient Follow-up duration: 2 years

Papers

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    History

      1. Started

        Jan 2021

      2. Main results due

        Jan 2025

      3. Finished

        Jan 2025

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