AzTrials
AzTrials

Multiple Sclerosis, Relapsing-RemittingPhase 4ALAIN01NCT02419378

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential

A Phase 4 study testing Alemtuzumab in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital Muenster at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Alemtuzumab is the active agent of a drug called Lemtrada®. In the European Union, Lemtrada® is approved for the treatment of a particular form of multiple sclerosis (the so called relapsing remitting form). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
Alemtuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteGermany
Study dates
Jun 2015to Nov 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Signed informed consent form (ICF)
  • Age 18 to 55 years old (inclusive) as of the date the ICF is signed
  • Diagnosis of MS according to the McDonald criteria 2010 and cranial MRI scan demonstrating white matter lesions attributable to MS within 10 years before Screening
  • Onset of MS symptoms (as determined by a neurologist, either at present or retrospectively) within 10 years of the date the ICF is signed
  • EDSS score 0.0 to 5.0 (inclusive) at Screening
  • Patients with (highly) active RRMS disease course indicated to receive alemtuzumab according to the following conditions (at least 1 out of 3 conditions has to be fulfilled): 1. ≥2 MS relapses within 24 months, 2. clinical (≥1 relapse) or MRI (new gadolinium enhancing lesions) disease activity under therapy with other diseasemodifying therapies, 3. severe relapse with high disease activity (≥9 T2 hyperintense Lesions and ≥1 gadolinium enhancing lesion) on MRI.
  • Completion of all vaccinations required by the applicable immunization guidelines published by "ständige Impfkommission" (STIKO)
  • History of chickenpox or positive test for antibodies against varicella zoster virus (VZV)

Who cannot join

  • Participation in another clinical trial at present or within 4 weeks of study entry. There may be exceptions at the discretion of the Investigator.
  • Has any progressive form of MS
  • Hypersensitivity to the active substance, or to any of the excipients of Lemtrada®
  • 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, to comply with the trial protocol, or to complete the study
  • Any disability acquired from trauma or another illness that could interfere with 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
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  • Known bleeding disorder (e.g,. dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation (DIC), fibrinogen deficiency, or clotting factor deficiency)
  • 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
  • History of malignancy, except basal skin cell carcinoma
  • Major psychiatric disorder that is not adequately controlled by treatment
  • Epileptic seizures that are not adequately controlled by Treatment
  • Active infection, e.g., deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation
  • In the Investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)
  • Seropositivity for human immunodeficiency virus (HIV)
  • Infection with hepatitis C Virus
  • Past or present hepatitis B infection (positive hepatitis B serology)
  • Active infection with human cytomegaly virus (HCMV), Epstein-Barr virus (EBV), varicella-zoster virus (VZV)
  • Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
  • Invasive fungal infections in history and at present
  • Cervical cytology other than PAP I or PAP II (Papanicolaou) or cervical high risk human papillomavirus (HPV) positivity
  • Any other illness or infection (latent or active) that, in the Investigator's opinion, could be exacerbated by study medication
  • Differential blood count < lower limit of normal (LLN) at Screening
  • Confirmed platelet count < the LLN of the evaluating laboratory at Screening or documented at <100,000/μL within the past year on a sample without platelet clumping
  • Presence (i.e., above the ULN) of anti-thyroid stimulating hormone receptor antibodies (anti-TSHR) and anti-thyroid peroxidase antibody (anti-TPO)
  • Any hepatic or renal function value grade 2 or higher at Screening, with the exception of hyperbilirubinemia due to Gilbert's syndrome. See Table below, drawn from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (CTCAE), published 28 May 2009.
  • Hepatic
  • Bilirubin >1.5 × ULN
  • SGOT/AST >3.0 × ULN
  • SGPT/ALT >3.0 × ULN
  • Alkaline phosphatase >2.5 × ULN
  • Renal
  • Creatinine > 1.5 × ULN
  • Vaccination less than 6 weeks prior to treatment with Lemtrada.
  • Treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion
  • Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
  • Inability to undergo MRI with gadolinium administration
  • Of childbearing potential with a positive serum pregnancy test, pregnant or lactating
  • Female patients of childbearing potential: Unwilling to agree to use a reliable and acceptable contraceptive method (Pearl index <1) throughout the study period. These methods include: hormone releasing intrauterine device (IUD), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Münster, Klinik für Allgemeine Neurologie

    Münster, 48149

Other trials in Germany

About this study

Alemtuzumab is the active agent of a drug called Lemtrada®. In the European Union, Lemtrada® is approved for the treatment of a particular form of multiple sclerosis (the so called relapsing remitting form). The excellent efficacy of the drug justifies its administration albeit a high risk of considerable side effects. In this context, so called secondary (occurring after the administration of Lemtrada®) autoimmune diseases are of particular importance. In these diseases the immune system acts against structures of the body itself; the reasons are still unknown. Autoimmune diseases may even occur several years after treatment with Lemtrada®. Therefore, patients who once received the drug need to undergo intensive long term health monitoring.

This study aims to elucidate which mechanisms cause to the positive and negative effects of Lemtrada®.

The study includes patients only, who suffer from multiple sclerosis and are indicated to be treated with Lemtrada®. All patients receive the drug according to the official recommendations.

Being tested
Alemtuzumab
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlemtuzumabDrug

Study groups in NCT02419378
Study groupRoleWhat they receive
alemtuzumabExperimentalAdministration 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.
Receives: Drug: Alemtuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change from baseline in naïve CD4 positive T cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  2. Relative change from baseline in naïve CD4 positive T cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  3. Relative change from baseline in naïve CD8 positive T cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  4. Absolute change from baseline in naïve CD8 positive T cell counts in peripheral blood

    12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  5. Absolute change from baseline in CD4 positive T effector cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  6. Relative change from baseline in CD4 positive T effector cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  7. Absolute change from baseline in CD8 positive T effector cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  8. Absolute change from baseline in CD4 positive T memory cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  9. Relative change from baseline in CD4 positive T memory cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  10. Absolute change from baseline in CD8 positive T memory cell counts peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  11. Relative change from baseline in CD8 positive T memory cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  12. Absolute change from baseline in CD4 positive regulatory T cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  13. Relative change from baseline in CD4 positive regulatory T cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  14. Absolute change from baseline in CD8 positive regulatory T cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  15. Relative change from baseline in CD8 positive regulatory T cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  16. Absolute change from baseline in Th1 T-helper cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  17. Relative change from baseline in Th1 T-helper cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  18. Absolute change from baseline in Th2 T-helper cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  19. Relative change from baseline in Th2 T-helper cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  20. Absolute change from baseline in Th17 T-helper cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  21. Relative change from baseline in Th17 T-helper cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  22. Absolute change from baseline in recent bone marrow emigrant B cell counts peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  23. Relative change from baseline in recent bone marrow emigrant B cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  24. Absolute change from baseline in mature naïve B cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  25. Relative change from baseline in mature naïve B cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  26. Absolute change from baseline in memory B cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  27. Relative change from baseline in memory B cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  28. Absolute change from baseline in plasma cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  29. Relative change from baseline in plasma cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  30. Absolute change from baseline in CD56bright natural killer cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  31. Relative change from baseline in CD56bright natural killer cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  32. Absolute change from baseline in CD56dim natural killer cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  33. Relative change from baseline in CD56dim natural killer cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  34. Absolute change from baseline in natural killer T cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  35. Relative change from baseline in natural killer T cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  36. Absolute change from baseline in CD303+ plasmacytoid dendritic cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  37. Relative change from baseline in CD303+ plasmacytoid dendritic cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  38. Absolute change from baseline in CD11c+ myeloid dendritic cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  39. Relative change from baseline in CD11c+ myeloid dendritic cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  40. Absolute change from baseline in CD141+ myeloid dendritic cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  41. Relative change from baseline in CD141+ myeloid dendritic cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  42. Absolute change from baseline in monocyte counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  43. Relative change from baseline in monocyte counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  44. Absolute change from baseline in macrophage counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  45. Relative change from baseline in macrophage counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  46. Absolute change from baseline in myeloid-derived suppressor cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  47. Relative change from baseline in myeloid-derived suppressor cell counts in peripheral blood

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

Secondary outcomes (67)

  1. Absolute change from baseline in naïve CD4 positive T cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  2. Relative change from baseline in naïve CD4 positive T cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  3. Absolute change from baseline in naïve CD8 positive T cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  4. Relative change from baseline in naïve CD8 positive T cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  5. Absolute change from baseline in CD4 positive T effector cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  6. Relative change from baseline in CD4 positive T effector cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  7. Absolute change from baseline in CD8 positive T effector cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  8. Relative change from baseline in CD8 positive T effector cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  9. Absolute change from baseline in CD4 positive T memory cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  10. Relative change from baseline in CD4 positive T memory cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  11. Absolute change from baseline in CD8 positive T memory cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  12. Relative change from baseline in CD8 positive T memory cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  13. Absolute change from baseline in CD4 positive regulatory T cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  14. Relative change from baseline in CD4 positive regulatory T cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  15. Absolute change from baseline in CD8 positive regulatory T cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  16. Relative change from baseline in CD8 positive regulatory T cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  17. Absolute change from baseline in Th1 T-helper cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  18. Relative change from baseline in Th1 T-helper cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  19. Absolute change from baseline in Th2 T-helper cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  20. Relative change from baseline in Th2 T-helper cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  21. Absolute change from baseline in Th17 T-helper cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  22. Relative change from baseline in Th17 T-helper cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  23. Absolute change from baseline in recent bone marrow emigrant B cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  24. Relative change from baseline in recent bone marrow emigrant B cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  25. Absolute change from baseline in mature naïve B cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  26. Relative change from baseline in mature naïve B cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  27. Absolute change from baseline in memory B cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  28. Relative change from baseline in memory B cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  29. Absolute change from baseline in plasma cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  30. Relative change from baseline in plasma cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  31. Absolute change from baseline in CD56bright natural killer cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  32. Relative change from baseline in CD56bright natural killer cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  33. Absolute change from baseline in CD56dim natural killer cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  34. Relative change from baseline in CD56dim natural killer cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  35. Absolute change from baseline in natural killer T cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  36. Relative change from baseline in natural killer T cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  37. Absolute change from baseline in CD303+ plasmacytoid dendritic cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  38. Relative change from baseline in CD303+ plasmacytoid dendritic cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  39. Absolute change from baseline in CD11c+ myeloid dendritic cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  40. Relative change from baseline in CD11c+ myeloid dendritic cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  41. Absolute change from baseline in CD141+ myeloid dendritic cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  42. Relative change from baseline in CD141+ myeloid dendritic cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  43. Absolute change from baseline in monocyte counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  44. Relative change from baseline in monocyte counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  45. Absolute change from baseline in macrophage counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  46. Relative change from baseline in macrophage counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  47. Absolute change from baseline in myeloid-derived suppressor cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  48. Relative change from baseline in myeloid-derived suppressor cell counts in cerebrospinal fluid

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  49. Activation status of cell surface receptors on T cells fom peripheral blood as assessed by flow cytometry

    Relative and absolute change from baseline of mean fluorescence intensity (MFI) and of proportion of positive cells regarding CD25, HLA-DR, LFA-1, CD29, CD69, CD71 expression

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  50. Activation status of cell surface receptors on T cells from cerebrospinal fluid as assessed by flow cytometry

    Relative and absolute change from baseline of mean fluorescence intensity (MFI) and of proportion of positive cells regarding CD25, HLA-DR, LFA-1, CD29, CD69, CD71 expression

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  51. Expression of co-inhibitory molecules by T cells from peripheral blood as assessed by flow cytometry

    Relative and absolute change from baseline of MFI and of proportion of positive cells regarding PD-1 = CD279, ICOS = CD278, TIM-3, CTLA4 expression

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  52. Expression of co-inhibitory molecules by T cells from cerebrospinal fluid as assessed by flow cytometry

    Relative and absolute change from baseline of MFI and of proportion of positive cells regarding PD-1 = CD279, ICOS = CD278, TIM-3, CTLA4 expression

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  53. Effector functions of CD4 and CD8 positive T cells from peripheral blood

    • Relative and absolute change from baseline of the results of cell proliferation assays assessed as percentage of proliferated cells
    • Relative and absolute change from baseline of cytokine production measurement assessed as concentration
    • Relative and absolute change from baseline of cytolytic activity assessed by flow cytometry measurement of MFI and proportion of positive cells regarding Granzyme B, Perforin and CD107a expression
    • Relative and absolute change from baseline of intracellular calcium response assessed as concentration

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  54. Effector functions of CD4 and CD8 positive T cells from cerebrospinal fluid

    • Relative and absolute change from baseline of the results of cell proliferation assays assessed as percentage of proliferated cells
    • Relative and absolute change from baseline of cytokine production measurement assessed as concentration
    • Relative and absolute change from baseline of cytolytic activity assessed by flow cytometry measurement of MFI and proportion of positive cells regarding Granzyme B, Perforin and CD107a expression
    • Relative and absolute change from baseline of intracellular calcium response assessed as concentration

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  55. Migrational capacity of T cells from peripheral blood

    • Relative and absolute change from baseline MFI and proportion of positive cells assessed by flow cytometry expression analysis of CD11a, CD31, CD44, CD49d, CCR5, CCR6, CCR7
    • Absolute and relative change of cell numbers of migrated cells compared to baseline assessed in an in vitro model by flow cytometry analysis

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  56. Migrational capacity of T cells from cerebrospinal fluid

    • Relative and absolute change from baseline MFI and proportion of positive cells assessed by flow cytometry expression analysis of CD11a, CD31, CD44, CD49d, CCR5, CCR6, CCR7
    • Absolute and relative change of cell numbers of migrated cells compared to baseline assessed in an in vitro model by flow cytometry analysis

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  57. Spectratyping of the T cell repertoire of T cells from peripheral blood concerning the expansion of distinct clones

    • Relative and absolute change from baseline for complexity scores
    • Qualitative comparison of the distribution of CDR3 sequences

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  58. Spectratyping of the T cell repertoire of T cells from cerebrospinal fluid concerning the expansion of distinct clones

    • Relative and absolute change from baseline for complexity scores
    • Qualitative comparison of the distribution of CDR3 sequences

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  59. Regulatory T-cell function in peripheral blood

    • Relative and absolute change from baseline in production of TGF-beta and IL-10 of CD4+CD25+FOXP3+ regulatory T cells
    • Suppression of T cell proliferation: Relative and absolute change from baseline in responder T cell proliferation assessed by suppression assays

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  60. Regulatory T-cell function in cerebrospinal fluid

    • Relative and absolute change from baseline in production of TGF-beta and IL-10 of CD4+CD25+FOXP3+ regulatory T cells
    • Suppression of T cell proliferation: Relative and absolute change from baseline in responder T cell proliferation assessed by suppression assays

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  61. Relative and absolute change from baseline in the concentration of markers in the cerebrospinal fluid

    • S100β
    • Tau
    • phospho-Tau
    • β-Amyloid
    • Neurofilament (low weight)
    • Neurofilament (high weight)
    • N-acetylaspartate (NAA)
    • Tubulin
    • Actin
    • neuron-specific enolase (NSE)
    • glial fibrillary acidic protein (GFAP)

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  62. Relative and absolute change from baseline in neuronal activity, action potential generation and cellular integrity by obtained human CSF supernatant samples using multi-electrode arrays

    Measured: 12, 24 and 36 months after initiation of investigational treatment on an optional basis

  63. Relative and absolute change from baseline in the concentration of neurotrophic factors in the peripheral blood

    • Nerve growth factor (NGF)
    • brain-derived neurotrophic factor (BDNF)
    • neurotrophin-3 (NT-3)
    • and neurotrophin-4 (NT-4)
    • ciliary neurotrophic factor (CNTF)

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  64. Relative and absolute change from baseline in the concentration of neurotrophic factors in cerebrospinal fluid

    • Nerve growth factor (NGF)
    • brain-derived neurotrophic factor (BDNF)
    • neurotrophin-3 (NT-3)
    • and neurotrophin-4 (NT-4)
    • ciliary neurotrophic factor (CNTF)

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  65. Percent change from Baseline in the following MRI findings which are defined as markers for neurodegeneration: MRI-T1-measured cerebral volume, MRI-T1-measured number of black holes

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  66. Relative and absolute change from baseline in retinal nerve fiber layer thickness (assessment by optical coherence tomography)

    Measured: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.

  67. Data on Adverse Events

    Clinically significant deteriorations from baseline in vital signs, results of physical examination and laboratory assessments in blood or CSF will be documented as Adverse Events

    Measured: Each day when the patient has a consultation with the investigator

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJul 2020
  4. Study completionNov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02419378
Sponsor's protocol ID
UKM12_0026
Other IDs
U1111-1156-6489
Acronym
ALAIN01
Status last verified
Oct 2021
First submitted
31 Mar 2015
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
No

Publications

  • Ruck T, Afzali AM, Lukat KF, Eveslage M, Gross CC, Pfeuffer S, Bittner S, Klotz L, Melzer N, Wiendl H, Meuth SG. ALAIN01--Alemtuzumab in autoimmune inflammatory neurodegeneration: mechanisms of action and neuroprotective potential. BMC Neurol. 2016 Mar 10;16:34. doi: 10.1186/s12883-016-0556-9.

    PubMed 26966029

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alemtuzumab in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital Muenster at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change from baseline in naïve CD4 positive T cell counts in peripheral blood (time frame: 12, 24 and 36 months after initiation of investigational treatment. In addition on an optional basis: 6, 18 and 30 months after treatment initiation.). The study lists 47 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02419378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.

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