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IL-11 in the Development of Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735823
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
Since the last submission, the investigator have further characterized the potential of IL--11 to induce encephalitogenic CD4+IL--17A+, IL--21+ and GM--CSF+ cells, which upon passive transfer induced severe RREAE with IL--17A+CCR6+ CD4+ cell, neutrophil, CD8+ and B--cell accumulation within the CNS (manuscript submitted for publication). These findings confirmed our hypothesis and further characterization of the IL--11--induced encephalitogenic CD4+ cells will be performed as planned in the grant proposal

Condition or disease Intervention/treatment
Multiple Sclerosis Other: No intervention, just collect blood samples and CSF samples

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Role of IL-II in the Development of Autoimmune Response in Multiple Sclerosis
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention, just collect blood samples and CSF samples
    No intervention
    Other Name: No intervention


Primary Outcome Measures :
  1. Adhesion marker expression of IL-11 producing CD4 T cells in the CNS and peripheral [ Time Frame: baseline ]
    surface adhesion marker Vla-4,Vla-2 and ICAM-1 expression pattern

  2. Cytokine receptor expression of IL-11 producing CD4 T cells in the CNS and peripheral [ Time Frame: baseline ]
    cytokine receptor IL1R,IL6R,IL23R,IL11RA,IL21R and IL17RA expression pattern

  3. Chemokine receptor expression of IL-11 producing CD4 T cells in the CNS and peripheral [ Time Frame: baseline ]
    chemokine receptor CXCR3,CCR7,CCR6,CCR10 and CCR4 expression

  4. transcription factor expression of IL-11 producing CD4 T cells in the CNS and peripheral [ Time Frame: baseline ]
    transcription factor pstat3, Gata3, Tbet,RORrt and Foxp3 expression pattern


Biospecimen Retention:   Samples With DNA
Blood and CSF samples.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
56 untreated patients with CIS according to the Revised McDonald Diagnostic Criteria and 40 control subjects with no evidence of the inflammatory diseases will be enrolled. Female and male subjects will be enrolled.
Criteria

Inclusion Criteria:

First clinical presentation and at least two central nervous system MRI lesions consistent with demyelinating disease;

Age 18-65 inclusive;

Extended disability status score (EDSS) 1.5-5.5;

No immunomodulatory or immunosuppresive therapy prior to the enrollment in the study.

Exclusion Criteria:

Concomitant infection;

Significant medical and psychiatric condition at the disgression of principal investigator;

Pregnant women;

Children and patients participating in research trials will not be enrolled in this study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735823


Contacts
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Contact: Silva Markovic-Plese, MD PhD 215-955-6871 silva.markovic-plese@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19446
Contact: Silva Markovic-Plese, MD PhD    215-955-6871    silva.Markovic-Plese@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Silva Markovic-Plese, MD PhD Thomas Jefferson University
Additional Information:

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03735823    
Other Study ID Numbers: 080-19000-S31301
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Investigators probably share data with other potential collaborators for further research

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Jefferson University:
IL-11 T cell migration
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases