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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De novo patients with alemtuzumab | De novo patients prior and after alemtuzumab treatment initiation |
| |
| Alemtuzumab treatment | Patients under alemtuzumab treatment |
| |
| Extended alemtuzumab treatment | Patients requiring more than two alemtuzumab infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alemtuzumab Injection [Lemtrada] | Drug | Administration of 2 courses of alemtuzumab at an interval of 1 year. Course 1: Intravenous infusion of 12 mg alemtuzumab per day on 5 consecutive days. Course 2: Intravenous infusion of 12 mg alemtuzumab per day on 3 consecutive days. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute and relative change of cell-counts compared to baseline of T cell subsets in the peripheral blood (every 6 months) | • T cell subsets:
| 36 month |
| Absolute and relative change of cell-counts compared to baseline of B-cell subsets in the peripheral blood (every 6 months) | • B cell subsets:
| 36 month |
| Absolute and relative change of cell-counts compared to baseline of natural killer cells in the peripheral blood (every 6 months) | • Natural killer cells:
| 36 month |
| Absolute and relative change of cell-counts compared to baseline of antigen-presenting cells in the peripheral blood (every 6 months) | • Antigen-presenting cells:
| 36 month |
| Absolute and relative change of cell-counts compared to baseline of myeloid-derived suppressor cells in the peripheral blood (every 6 months) | • Myeloid-derived suppressor cells | 36 month |
| Change from baseline in levels of markers of autoimmunity (ANA, cANCA and pANCA) in the serum (every 6 months): | - IFT (immunoflescence-test) of ANA, cANCA and pANCA | 36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Functional characterization of T-cells and B cells in the peripheral blood (every 6 months) | 36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical related data: Analysis of MRI scans | - Number and location of lesions in MRI scans will be count | 36 month |
| Clinical related data: Evaluation of disease activity and manifestation (EDSS) in comparison to baseline (every 6 months) |
Inclusion Criteria:
Exclusion Criteria:
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The patient population will be patients with active RRMS, which will be rectruited in multiple KKNMS (Kompetenznetz Multiple Sklerose) centres.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tobias Ruck, Dr.med. | Contact | tobias.ruck@ukmuenster.de |
| Name | Affiliation | Role |
|---|---|---|
| Sven Meuth, Prof. | Department of Neurology with Institute of Translational Neurology, University Hospital Muenster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33324905 | Derived | Bierhansl L, Ruck T, Pfeuffer S, Gross CC, Wiendl H, Meuth SG. Signatures of immune reprogramming in anti-CD52 therapy of MS: markers for risk stratification and treatment response. Neurol Res Pract. 2019 Dec 13;1:40. doi: 10.1186/s42466-019-0045-x. eCollection 2019. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Change from baseline in levels of markers of autoimmunity (anti-dsDNA) in the serum (every 6 months): | - RIA (radioimmunoassay) of anti-dsDNA | 36 month |
| Change from baseline in levels of markers of autoimmunity (anti-TSH-Receptor) in the serum (every 6 months): | - Levels of anti-TSH-Receptor (U/ml) | 36 month |
| Change from baseline in levels of markers of autoimmunity(anti-TPO) in the serum (every 6 months): | - Levels of anti-TPO (U/ml) | 36 month |
| Change from baseline in levels of markers of autoimmunity (Rheumatoid factor) in the serum (every 6 months): | - Levels of Rheumatoid factor (U/ml) | 36 month |
| Change from baseline in levels of markers of autoimmunity (anti-CCP) in the serum (every 6 months): | - Levels of anti-CCP (U/ml) | 36 month |
| Change from baseline in levels of markers of autoimmunity (anti-GBM) in the serum (every 6 months): | - Levels of anti-GBM (U/ml) | 36 month |
| Change from baseline in levels of markers of autoimmunity (antiplatelet antibodies) in the serum (every 6 months): | - Levels of antiplatelet antibodies (U/ml) | 36 month |
• Expanded Disability Status Scale (EDSS):
| 36 month |
| Clinical related data: Evaluation of disease activity and manifestation (MSFC) in comparison to baseline (every 6 months) | • Multiple Sclerosis Functional Composite (MSFC):
| 36 month |
| Clinical related data: Observation of relapse rates | - Number and time of relapses will be counted | 36 month |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |