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

German University in Cairo

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Other: Blood sample collection

Study type: Observational

Funder types: Other

Identifiers

NCT05735067

MSINF

Details and patient eligibility

About

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

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

138 participants in 2 patient groups

Group 1

Description:

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

Treatment:

Other: Blood sample collection

Group 2

Description:

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

Treatment:

Other: Blood sample collection