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

Multiple Sclerosis Clinical Trial

Official title:

The Effect of Ocrelizumab on the Peripheral Lymphocyte Immunophenotypes With Suppressive Capacity in Patients With Multiple Sclerosis Previously Treated With Disease Modifying Therapy - A Prospective Exploratory Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04874597
• Other study ID #: ML42254
• Status: Active, not recruiting
• Start date: November 15, 2021
• Est. completion date: November 2023

Study information

• Verified date: April 2023
• Source: Haydarpasa Numune Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

This is a 24-month, prospective, exploratory, observational study to investigate immune phenotypes in patients with MS following treatment with ocrelizumab. The study will be conducted on Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital, Neurology Department.

The decision to treat with ocrelizumab must be made prior to and independently from the proposal to enroll the patient into this study and in line with the Summary of Product Characteristics (SmPC) approved by the Turkish Ministry of Health.

Data will be recorded at screening visit, baseline visit (month 0), second visit on 6th month, third visit on 12th month and last visit (end of the study [EOS]) on 24th month according to local clinic practice. Optional ad hoc visits could be conducted if relapse of MS or infection after vaccination occurs during ocrelizumab treatment.

The duration of the study for each patient will be 24 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Turkey	Health Sciences University Istanbul Haydarpasa Numune Training and Research Hospital, Neurology Department	Istanbul	Uskudar

Sponsors (2)

Lead Sponsor	Collaborator
Dr Recai Turkoglu	Health Sciences University Istanbul Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socio-demographic data	Date of birth, sex, country of birth	Baseline (month 0)
Other	Previous MS treatment history: DMT agents and other treatments used for MS before ocrelizumab initiation	Number (%) patients receiving any DMT agents and other treatments	Screening or baseline (month 0)
Other	Previous MS treatment history: dosing, route, and treatment duration	Treatment duration: Date of first and last administration for first line DMT agent and other medications used for MS before ocrelizumab initiation	Screening or baseline (month 0)
Other	Previous MS treatment history: reasons for discontinuation of each previous MS treatment	Reasons for discontinuation includes: inefficacy/high disease activity, relapse, adverse event, lack of compliance or other.	Screening or baseline (month 0)
Other	Medical history data	Medical history data includes: comorbidities, current and prior treatments for diseases other than MS, hospitalization, surgery, allergies, family history and vaccination history within the last five years.	Baseline (month 0)
Other	Vital signs	• Heart rate	Baseline (month 0), month 6, month 12 and month 24
Other	Vital signs	• Blood pressure	Baseline (month 0), month 6, month 12 and month 24
Other	Vital signs	• Body temperature	Baseline (month 0), month 6, month 12 and month 24
Other	Vital signs	• Respiratory rate	Baseline (month 0), month 6, month 12 and month 24
Other	Physical examination	• Height	Baseline (month 0), month 6, month 12 and month 24
Other	Physical examination	• Weight	Baseline (month 0), month 6, month 12 and month 24
Other	Physical examination	• Body mass index	Baseline (month 0), month 6, month 12 and month 24
Other	Physical examination	• Complete neurological and physical examination	Baseline (month 0), month 6, month 12 and month 24
Other	Covid-19 assessment	Covid-19 polymerase chain reaction (PCR) test result (if available)	Screening, baseline (month 0), month 6, month 12 and month 24
Other	Covid-19 assessment	Treatment (if available)	Screening, baseline (month 0), month 6, month 12 and month 24
Other	MS Assessment:	• Expanded Disability Status Scale (EDSS)	Baseline (month 0), month 6, month 12 and month 24
Other	MS Assessment:	• Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)	Baseline (month 0), month 6, month 12 and month 24
Other	MS Assessment:	• Multiple Sclerosis Functional Composite (MSFC)	Baseline (month 0), month 6, month 12 and month 24
Other	MS Assessment:	• Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)	Baseline (month 0), month 6, month 12 and month 24
Other	MS Assessment:	• Symbol Digit Modalities Test (SDMT)	Baseline (month 0), month 6, month 12 and month 24
Other	MS Assessment:	• Nine-Hole Peg Test (9-HPT)	Baseline (month 0), month 6, month 12 and month 24
Other	MS Assessment:	• Timed 25-foot walk test (25-FWT)	Baseline (month 0), month 6, month 12 and month 24
Primary	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
Primary	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	Correlation between changes in T and B cell capacity and function during course of ocrelizumab therapy.		Baseline (month 0), month 6 and month 12
Secondary	Clinical improvement	Clinical improvement will be confirmed if an increase of less than half a step on the Expanded Disability Status Scale and less than one attack were observed during the first 12 months of ocrelizumab treatment.	Baseline (month 0), month 6 and month 12
Secondary	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
Secondary	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