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The Impact of Body Weight on Clinical and Immunological Outcomes in Relapse-Remitting Multiple Sclerosis Patients

NCT ID: NCT05735067

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-07-30

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Keywords

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Multiple Sclerosis, IFB 1a

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

RRMS patients who received Interferon beta 1a and have normal weight

Blood sample collection

Intervention Type OTHER

5 ml of blood samples were withdrawn from RRMS patients

Group 2

RRMS patients who received Interferon beta 1a and have are obese

Blood sample collection

Intervention Type OTHER

5 ml of blood samples were withdrawn from RRMS patients

Interventions

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Blood sample collection

5 ml of blood samples were withdrawn from RRMS patients

Intervention Type OTHER

Eligibility Criteria

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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.
* Kurtzke EDSS step 0.0 - 6.0.
* At the time of screening, being treated with a stable dose of Interferon Beta 1a for at least 6 months.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German University in Cairo

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Youssef Elsayed

Research assistant in Clinical Pharmacology and Pharmacogenomics Research Gruop

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nasser Institute for Research and Treatment

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 19446274 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10852536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20439848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21530402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19933767 (View on PubMed)

Other Identifiers

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MSINF

Identifier Type: -

Identifier Source: org_study_id