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

Our study aimed to investigate the effect of interferon beta 1a on the clinical and immunological parameters in Egyptian relapse-remitting multiple sclerosis patients

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Blood sample collection

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.

• Study Type: Observational
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 1053
    • Nasser Institute for Research and Treatment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Egyptian Relapsing-Remitting Multiple Sclerosis Patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; RRMS patients who received Interferon beta 1a and have normal weight	Other: Blood sample collection; 5 ml of blood samples were withdrawn from RRMS patients
Group 2; RRMS patients who received Interferon beta 1a and have are obese	Other: Blood sample collection; 5 ml of blood samples were withdrawn from RRMS patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISA	Anti-inflammatory and disease activity biomarkers	Patients were treated with INF B 1a for at least 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between IL 22 levels and patients' response to interferon beta 1a, measured by ELISA	Anti-inflammatory and disease activity biomarkers	Patients were treated with INF B 1a for at least 6 months
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.	Patients were treated with INF B 1a for at least 6 months
Correlation between malondialdehyde levels and patients' response to interferon beta 1a	oxidative stress biomarkers	Patients were treated with INF B 1a for at least 6 months
Correlation between MRI load and Patients' response to interferon beta 1a	Determination of T2 lesions	Patients were treated with INF B 1a for at least 6 months
Correlation between body mass index and patients' response to interferon beta 1 a	Body weight measurement	Patients were treated with INF B 1a for at least 6 months

Collaborators and Investigators

• Sponsor: German University in Cairo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Multiple Sclerosis, IFB 1a
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Body Weight
• Other Study ID Numbers: MSINF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No