The Impact of Body Weight on Clinical and Immunological Outcomes in Relapse-Remitting Multiple Sclerosis Patients
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Blood sample collection
- Registration Number
- NCT05735067
- Lead Sponsor
- German University in Cairo
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 138
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 2 Blood sample collection RRMS patients who received Interferon beta 1a and have are obese Group 1 Blood sample collection RRMS patients who received Interferon beta 1a and have normal weight
- Primary Outcome Measures
Name Time Method Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISA Patients were treated with INF B 1a for at least 6 months Anti-inflammatory and disease activity biomarkers
- Secondary Outcome Measures
Name Time Method 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 Anti-inflammatory and disease activity biomarkers
Correlation between MRI load and Patients' response to interferon beta 1a Patients were treated with INF B 1a for at least 6 months Determination of T2 lesions
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 Body weight measurement
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 Determination disability level (0 - 6), The lowest value means that it is best outcome and the highest value is the worst outcome.
Correlation between malondialdehyde levels and patients' response to interferon beta 1a Patients were treated with INF B 1a for at least 6 months oxidative stress biomarkers
Trial Locations
- Locations (1)
Nasser Institute for Research and Treatment
🇪🇬Cairo, Egypt