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

NCT05735067 | Unknown

• 1 other identifier: MSINF
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, IFB 1a

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Correlation between IL 22 levels and patients' response to interferon beta 1a, measured by ELISA

  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

  Patients were treated with INF B 1a for at least 6 months

• Correlation between malondialdehyde levels and patients' response to interferon beta 1a

  Patients were treated with INF B 1a for at least 6 months

• Correlation between MRI load and Patients' response to interferon beta 1a

  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

  Patients were treated with INF B 1a for at least 6 months

Study Arms (2)

Group 1

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

Other: Blood sample collection

Group 2

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

Other: Blood sample collection

Interventions

Blood sample collection OTHER

5 ml of blood samples were withdrawn from RRMS patients

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Egyptian Relapsing-Remitting Multiple Sclerosis Patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• German University in Cairo: lead

Study Sites (1)

Nasser Institute for Research and Treatment

Cairo, 1053, Egypt

Location

Related Publications (5)

• 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.

  PMID: 19446274 BACKGROUND

• 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.

  PMID: 10852536 BACKGROUND

• 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.

  PMID: 20439848 BACKGROUND

• 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.

  PMID: 21530402 BACKGROUND

• 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.

  PMID: 19933767 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant in Clinical Pharmacology and Pharmacogenomics Research Gruop

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: February 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 30, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

EG (1)