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

Study Overview
=================
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.

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

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>RRMS patients who received Interferon beta 1a and have normal weight | Other: Blood sample collection<br>* 5 ml of blood samples were withdrawn from RRMS patients<br>|
| Group 2<br>RRMS patients who received Interferon beta 1a and have are obese | Other: Blood sample collection<br>* 5 ml of blood samples were withdrawn from RRMS patients<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, IFB 1a