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The Impact of Interferon Beta 1a on Egyptian Relapse-Remitting Multiple Sclerosis Patients

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Blood sample collection
Sponsored by
German University in Cairo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, IFB 1a

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18 and 50 years at time of signing informed consent form. Relapsing- remitting multiple sclerosis as per the McDonald 2017 criteria, including an MRI brain satisfying the 2017 radiological criteria. Full-field visual evoked potential (VEP) P100 latency in at least one eye of ≥118 ms. Kurtzke EDSS step 0.0 - 6.0. At the time of screening, being treated with a stable dose for at least 6 months of a category 1 multiple sclerosis DMT or for at least 2 years with a category 2 DMT. Exclusion Criteria: they had been treated in the last 30 days with methylprednisolone they had changed their IFN-β preparation within the last 18 months they had other chronic diseases associated with MS they had been previously treated with immunosuppressive agents

Sites / Locations

  • Nasser Institute for Research and TreatmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group 1

Arm Description

RRMS patients who received Interferon beta 1a

Outcomes

Primary Outcome Measures

Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISA
Anti-inflammatory and disease activity biomarkers

Secondary Outcome Measures

Correlation between IL 22 levels and patients' response to interferon beta 1a, measured by ELISA
Anti-inflammatory and disease activity biomarkers
Correlation between Expanded Disability Status Scale and patients' response to interferon beta 1a
Determination disability level (0 - 6), The lowest value means that it is best outcome and the highest value is the worst outcome.
Correlation between malondialdehyde levels and patients' response to interferon beta 1a
oxidative stress biomarkers
Correlation between MRI load and Patients' response to interferon beta 1a
Determination of T2 lesions
Correlation between body mass index and patients' response to interferon beta 1 a
Body weight measurement

Full Information

First Posted
February 9, 2023
Last Updated
February 26, 2023
Sponsor
German University in Cairo
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1. Study Identification

Unique Protocol Identification Number
NCT05735067
Brief Title
The Impact of Interferon Beta 1a on Egyptian Relapse-Remitting Multiple Sclerosis Patients
Official Title
The Impact of Interferon Beta 1a on Egyptian Relapse-Remitting Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German University in Cairo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Our study aimed to investigate the effect of interferon beta 1a on the clinical and immunological parameters in Egyptian relapse-remitting multiple sclerosis patients
Detailed Description
Until recently, relapsing-remitting multiple sclerosis (RRMS) was considered a homogeneous form of multiple sclerosis (MS). Variability both in the immunopathology of active demyelinating lesions in MS and in response to immunomodulatory treatments has demonstrated that RRMS is a heterogeneous form of MS. An overwhelming number of trials have supported the use of interferon-β (IFN-β) as a first-line immunomodulatory treatment in RRMS. Approximately 30% of IFN-β treated RRMS patients are non-responders (NR) to treatment. Despite vast clinical experience in the use of IFN-β, its mechanisms of action have not been fully clarified. Interleukin-17 (IL-17) is a proinflammatory cytokine that is secreted by a lineage of T cells named Th17 cells. The Th17 chemokine pathways are essential for the development of central nervous system (CNS) autoimmune diseases such as MS. A high IL-17 concentration in the serum. of people with RRMS is associated with nonresponse to IFN-β therapy. Some animal and human studies have shown that IFN-β inhibits the activity of Th17 cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, IFB 1a

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
RRMS patients who received Interferon beta 1a
Intervention Type
Other
Intervention Name(s)
Blood sample collection
Intervention Description
5 ml of blood samples were withdrawn from RRMS patients
Primary Outcome Measure Information:
Title
Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISA
Description
Anti-inflammatory and disease activity biomarkers
Time Frame
Patients were treated with INF B 1a for at least 6 months
Secondary Outcome Measure Information:
Title
Correlation between IL 22 levels and patients' response to interferon beta 1a, measured by ELISA
Description
Anti-inflammatory and disease activity biomarkers
Time Frame
Patients were treated with INF B 1a for at least 6 months
Title
Correlation between Expanded Disability Status Scale and patients' response to interferon beta 1a
Description
Determination disability level (0 - 6), The lowest value means that it is best outcome and the highest value is the worst outcome.
Time Frame
Patients were treated with INF B 1a for at least 6 months
Title
Correlation between malondialdehyde levels and patients' response to interferon beta 1a
Description
oxidative stress biomarkers
Time Frame
Patients were treated with INF B 1a for at least 6 months
Title
Correlation between MRI load and Patients' response to interferon beta 1a
Description
Determination of T2 lesions
Time Frame
Patients were treated with INF B 1a for at least 6 months
Title
Correlation between body mass index and patients' response to interferon beta 1 a
Description
Body weight measurement
Time Frame
Patients were treated with INF B 1a for at least 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 50 years at time of signing informed consent form. Relapsing- remitting multiple sclerosis as per the McDonald 2017 criteria, including an MRI brain satisfying the 2017 radiological criteria. Full-field visual evoked potential (VEP) P100 latency in at least one eye of ≥118 ms. Kurtzke EDSS step 0.0 - 6.0. At the time of screening, being treated with a stable dose for at least 6 months of a category 1 multiple sclerosis DMT or for at least 2 years with a category 2 DMT. Exclusion Criteria: they had been treated in the last 30 days with methylprednisolone they had changed their IFN-β preparation within the last 18 months they had other chronic diseases associated with MS they had been previously treated with immunosuppressive agents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Elsayed, master
Phone
+2001091282830
Email
mohamed.yosefelsayed@student.guc.edu.eg
Facility Information:
Facility Name
Nasser Institute for Research and Treatment
City
Cairo
ZIP/Postal Code
1053
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Hamed, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19446274
Citation
Rudick RA, Polman CH. Current approaches to the identification and management of breakthrough disease in patients with multiple sclerosis. Lancet Neurol. 2009 Jun;8(6):545-59. doi: 10.1016/S1474-4422(09)70082-1.
Results Reference
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PubMed Identifier
10852536
Citation
Lucchinetti C, Bruck W, Parisi J, Scheithauer B, Rodriguez M, Lassmann H. Heterogeneity of multiple sclerosis lesions: implications for the pathogenesis of demyelination. Ann Neurol. 2000 Jun;47(6):707-17. doi: 10.1002/1531-8249(200006)47:63.0.co;2-q.
Results Reference
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PubMed Identifier
20439848
Citation
Hesse D, Krakauer M, Lund H, Sondergaard HB, Langkilde A, Ryder LP, Sorensen PS, Sellebjerg F. Breakthrough disease during interferon-[beta] therapy in MS: No signs of impaired biologic response. Neurology. 2010 May 4;74(18):1455-62. doi: 10.1212/WNL.0b013e3181dc1a94.
Results Reference
background
PubMed Identifier
21530402
Citation
Axtell RC, Raman C, Steinman L. Interferon-beta exacerbates Th17-mediated inflammatory disease. Trends Immunol. 2011 Jun;32(6):272-7. doi: 10.1016/j.it.2011.03.008. Epub 2011 Apr 29.
Results Reference
background
PubMed Identifier
19933767
Citation
Brucklacher-Waldert V, Stuerner K, Kolster M, Wolthausen J, Tolosa E. Phenotypical and functional characterization of T helper 17 cells in multiple sclerosis. Brain. 2009 Dec;132(Pt 12):3329-41. doi: 10.1093/brain/awp289.
Results Reference
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The Impact of Interferon Beta 1a on Egyptian Relapse-Remitting Multiple Sclerosis Patients

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