Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response

NCT ID: NCT04082260

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2022-01-31

Brief Summary

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

De novo patients with alemtuzumab

De novo patients prior and after alemtuzumab treatment initiation

Alemtuzumab Injection [Lemtrada]

Intervention Type: 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.

Alemtuzumab treatment

Patients under alemtuzumab treatment

Alemtuzumab Injection [Lemtrada]

Intervention Type: 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.

Extended alemtuzumab treatment

Patients requiring more than two alemtuzumab infusions

Alemtuzumab Injection [Lemtrada]

Intervention Type: 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.

Interventions

Alemtuzumab Injection [Lemtrada]

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sven Meuth, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology with Institute of Translational Neurology, University Hospital Muenster

Locations

Department of Neurology

Münster, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Tobias Ruck, Dr.med.

Role: CONTACT

tobias.ruck@ukmuenster.de

Facility Contacts

Tobias Ruck

Role: primary

tobias.ruck@ukmuenster.de

References

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.

Reference Type: DERIVED

PMID: 33324905 (View on PubMed)

Other Identifiers

ProgramMS2017

Identifier Type: -

Identifier Source: org_study_id