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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05735067
Enrollment
138
Registered
2023-02-21
Start date
2022-02-01
Completion date
2025-07-30
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, IFB 1a

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.

Interventions

OTHERBlood sample collection

5 ml of blood samples were withdrawn from RRMS patients

Sponsors

German University in Cairo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISAPatients were treated with INF B 1a for at least 6 monthsAnti-inflammatory and disease activity biomarkers

Secondary

MeasureTime frameDescription
Correlation between IL 22 levels and patients' response to interferon beta 1a, measured by ELISAPatients were treated with INF B 1a for at least 6 monthsAnti-inflammatory and disease activity biomarkers
Correlation between Expanded Disability Status Scale and patients' response to interferon beta 1aPatients were treated with INF B 1a for at least 6 monthsDetermination 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 1aPatients were treated with INF B 1a for at least 6 monthsoxidative stress biomarkers
Correlation between MRI load and Patients' response to interferon beta 1aPatients were treated with INF B 1a for at least 6 monthsDetermination of T2 lesions
Correlation between body mass index and patients' response to interferon beta 1 aPatients were treated with INF B 1a for at least 6 monthsBody weight measurement

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026