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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05735067
• Other study ID #: MSINF
• Status: Active, not recruiting
• Start date: February 1, 2022
• Est. completion date: July 30, 2025

Study information

• Verified date: December 2023
• Source: German University in Cairo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: July 30, 2025
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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-ß preparation within the last 18 months
• they had other chronic diseases associated with MS
• they had been previously treated with immunosuppressive agents

Related Conditions & MeSH terms

• Body Weight
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Blood sample collection
5 ml of blood samples were withdrawn from RRMS patients

Locations

Country	Name	City	State
Egypt	Nasser Institute for Research and Treatment	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
German University in Cairo

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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