Multiple SclerosisNCT05735067
The Impact of Body Weight on Clinical and Immunological Outcomes in Relapse-Remitting Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by German University in Cairo at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Blood sample collection
- How many people
- 138 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 30 Jul 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Egyptian Relapsing-Remitting Multiple Sclerosis Patients
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Our study aimed to investigate the effect of interferon beta 1a on the clinical and immunological parameters in Egyptian relapse-remitting multiple sclerosis patients
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Blood sample collection
- Keywords
- Multiple Sclerosis, IFB 1a
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
5 ml of blood samples were withdrawn from RRMS patients
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | RRMS patients who received Interferon beta 1a and have normal weight Receives: Other: Blood sample collection | |
| Group 2 | RRMS patients who received Interferon beta 1a and have are obese Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISA
Anti-inflammatory and disease activity biomarkers
Measured: 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
Anti-inflammatory and disease activity biomarkers
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Patients were treated with INF B 1a for at least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Feb 2022
- Primary completion1 May 2023
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- German University in Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Youssef Elsayed, German University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735067
- Sponsor's protocol ID
- MSINF
- Status last verified
- Dec 2023
- First submitted
- 9 Feb 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19446274Lucchinetti 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.
PubMed 10852536Hesse 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.
PubMed 20439848Axtell 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.
PubMed 21530402Brucklacher-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.
PubMed 19933767
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Body Weight on Clinical and Immunological Outcomes in Relapse-Remitting Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05735067
- Acronym / sponsor ID
- MSINF
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, IFB 1a
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (actual)
- Lead sponsor
- German University in CairoUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Blood sample collectionRRMS patients who received Interferon beta 1a and have normal weight |
| Group 2 | – | Other: Blood sample collectionRRMS patients who received Interferon beta 1a and have are obese |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Egyptian Relapsing-Remitting Multiple Sclerosis Patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collection5 ml of blood samples were withdrawn from RRMS patients | Other | Group 1, Group 2 |
Primary outcome
Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISA
Time frame: Patients were treated with INF B 1a for at least 6 months
Anti-inflammatory and disease activity biomarkers
5 secondary outcomes
Correlation between IL 22 levels and patients' response to interferon beta 1a, measured by ELISA
Time frame: 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
Time frame: Patients were treated with INF B 1a for at least 6 months
Correlation between malondialdehyde levels and patients' response to interferon beta 1a
Time frame: Patients were treated with INF B 1a for at least 6 months
Correlation between MRI load and Patients' response to interferon beta 1a
Time frame: 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
Time frame: Patients were treated with INF B 1a for at least 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Background: PubMed 19446274Rudick 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.
- Background: PubMed 10852536Lucchinetti 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.
- Background: PubMed 20439848Hesse 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.
- Background: PubMed 21530402Axtell 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.
- Background: PubMed 19933767Brucklacher-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.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by German University in Cairo at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISA (time frame: Patients were treated with INF B 1a for at least 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05735067, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.