Status unknownMS (type not specified)NCT04082260

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

What it measured

Main measures

  • Absolute and relative change of cell-counts compared to baseline of T cell subsets in the peripheral blood (every 6 months)

    36 month

    Thinking and memoryImmune response
  • Absolute and relative change of cell-counts compared to baseline of B-cell subsets in the peripheral blood (every 6 months)

    36 month

    Thinking and memoryImmune response
  • Absolute and relative change of cell-counts compared to baseline of natural killer cells in the peripheral blood (every 6 months)

    36 month

    Immune response
  • Absolute and relative change of cell-counts compared to baseline of antigen-presenting cells in the peripheral blood (every 6 months)

    36 month

    Immune response
  • Absolute and relative change of cell-counts compared to baseline of myeloid-derived suppressor cells in the peripheral blood (every 6 months)

    36 month

  • Change from baseline in levels of markers of autoimmunity (ANA, cANCA and pANCA) in the serum (every 6 months):

    36 month

  • Change from baseline in levels of markers of autoimmunity (anti-dsDNA) in the serum (every 6 months):

    36 month

  • Change from baseline in levels of markers of autoimmunity (anti-TSH-Receptor) in the serum (every 6 months):

    36 month

  • Change from baseline in levels of markers of autoimmunity(anti-TPO) in the serum (every 6 months):

    36 month

  • Change from baseline in levels of markers of autoimmunity (Rheumatoid factor) in the serum (every 6 months):

    36 month

  • Change from baseline in levels of markers of autoimmunity (anti-CCP) in the serum (every 6 months):

    36 month

  • Change from baseline in levels of markers of autoimmunity (anti-GBM) in the serum (every 6 months):

    36 month

  • Change from baseline in levels of markers of autoimmunity (antiplatelet antibodies) in the serum (every 6 months):

    36 month

Other measures (1)

  • Functional characterization of T-cells and B cells in the peripheral blood (every 6 months)

    36 month

    Immune response

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: * Diagnosis of MS according to the McDonald criteria 2010 and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years before prior to signing the informed consent form (ICF) * Age > 18 years * Written informed consent to study participation Exclusion Criteria: * Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, or to complete the study * Any progressive form of MS * Any condition that serves as a contraindication for alemtuzumab treatment * Any disability acquired from trauma or another illness that could interfere with the evaluation of disability due to MS * Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage * Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis * Inability to undergo MRI with gadolinium administration

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

About this trial

In the sponsor's words

Alemtuzumab is a highly effective therapy in relapse remitting multiple sclerosis (RRMS). The aim of this study is to elucidate the mechanism of action of the neuroprotective potential of alemtuzumab in RRMS. Therefore, the investigators will semi-annually analyse blood samples of RRMS patients treated with alemtuzumab up to 36 months. Using in vitro/ ex vivo assays the investigators aim to detect and characterize immune cells including their functional activity. Furthermore, the study aims to combine this analysis with clinical data (MRI, EDSS: Expanded Disability Status Scale, MSFC: Multiple Sclerosis Functional Composite) to reveal the underlining mechanism of action of alemtuzumab to further improve its efficacy and safety for present and future patients.

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Jan 2017

    2. Main results due

      Jan 2022

    3. Finished

      Jan 2022

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error