Investigation of the Effect of Ocrelizumab on Peripheral Lymphocyte Immunophenotypes with Suppressive Capacity in MS

NCT04874597 | Active Not Recruiting

• 1 other identifier: ML42254
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab.

Conditions

Multiple Sclerosis

Keywords

Ocrelizumab; Disease modifying therapy; T cell; B cell

Outcome Measures

Primary Outcomes (2)

• Change from baseline in T cell capacity achieved by eliminating B cells as measured by flow cytometry.

  Change will be measured in absolute cell numbers and percentages from baseline to Month 6 and to Month 12.

  From baseline to month 6 and month 12

• Change from baseline in T cell function achieved by eliminating B cells as measured by flow cytometry.

  Change will be measured in absolute cell numbers and percentages from baseline to Month 6 and to Month 12.

  From baseline to month 6 and month 12

Secondary Outcomes (4)

• Correlation between changes in T and B cell capacity and function during course of ocrelizumab therapy.

  Baseline (month 0), month 6 and month 12

• Clinical improvement

  Baseline (month 0), month 6 and month 12

• Changes in T cells in case of relapse or infection after vaccination during ocrelizumab treatment by flow cytometry.

  From baseline (month 0) to month 6 and month 12

• Changes in B cells in case of relapse or infection after vaccination during ocrelizumab treatment by flow cytometry.

  From baseline (month 0) to month 6 and month 12

Other Outcomes (22)

• Socio-demographic data

  Baseline (month 0)

• Previous MS treatment history: DMT agents and other treatments used for MS before ocrelizumab initiation

  Screening or baseline (month 0)

• Previous MS treatment history: dosing, route, and treatment duration

  Screening or baseline (month 0)

Interventions

Ocrelizumab DRUG

Ocrelizumab treatment will be administered in accordance with the product characteristics approved in Turkey.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: MS patients will be stratified for gender to reflect epidemiological incidence of MS subtypes. Gender ratios (Female/Male) for RMS and PPMS are set for 2:1 and 1:1, respectively.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 20 MS patients who were previously treated with at least one of other DMT will be recruited. Participants will be recruited by specialized physicians who are experienced in the diagnosis and treatment of MS and ocrelizumab use. * Consecutive MS patients with an already planned ocrelizumab therapy will be screened for recruitment in study recruiting clinics. Ocrelizumab treatment will not be initiated to recruit study patients. * MS patients will be stratified for gender to reflect epidemiological incidence of MS subtypes. Gender ratios (Female/Male) for RMS and PPMS are set for 2:1 and 1:1, respectively.

You may qualify if:

• Adults (≥18 years old) with a diagnosis of relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) according to the 2017 revised McDonald criteria.
• Previous MS treatment with at least one of other DMT(\*). The patients can be without treatment before switching until the end of wash-out period of previous DMT(s) or until lymphocytes parameter is in normal range.
• Previous treatment change with the reasons inefficacy, safety related issues or lack of compliance.
• Decision to initiate ocrelizumab therapy (in accordance with the product characteristics approved in Turkey) has already been taken for the treatment of MS patient as part of routine clinical practice. The decision to treat with Ocrelizumab must be made prior to and independently from the proposal to enroll the patient into this study.
• Agreed and signed informed consent.
• (\*) A DMT is defined as any of the following drugs: Teriflunomide, Interferon beta 1a, Interferon beta 1b, Peginterferon beta 1a, Glatiramer acetate, Fingolimod, Daclizumab, Alemtuzumab, Cladribine, Dimethyl fumarate, and Natalizumab.

You may not qualify if:

• Previously treated with anti-CD20 therapy (rituximab, atacicept, belimumab or ofatumumab).
• Medical history of a malignancy, active infection (including Hepatitis B virus) or chronic inflammatory disease.
• Medical history or use of any medication other than a DMT as defined above which may affect immunophenotypes of the participants.

Sponsors & Collaborators

• Dr Recai Turkoglu: lead
• Haydarpasa Numune Training and Research Hospital: collaborator

Study Sites (1)

Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital, Neurology Department

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Prof

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: May 5, 2021
• Study Start: November 15, 2021
• Primary Completion: April 10, 2025
• Study Completion: April 15, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-04

Locations

TU (1)