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Trial record 3 of 17 for:    HLA-DRB1 AND DRB1

Polymorphisms of Interleukins, Glypican, and Human Leukocyte Antigen Genes and Treatment Response in Multiple Sclerosis. (WESTEMDRB1)

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ClinicalTrials.gov Identifier: NCT02769767
Recruitment Status : Unknown
Verified May 2016 by Jose Alfonso Cruz-Ramos, Instituto Jalisciense de Cancerologia.
Recruitment status was:  Recruiting
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Collaborators:
Instituto Mexicano del Seguro Social
University of Guadalajara
Information provided by (Responsible Party):
Jose Alfonso Cruz-Ramos, Instituto Jalisciense de Cancerologia

Brief Summary:
HLA-DRB1 * Gene and some genes involved in inflammation and immunity (IL-7R, GPC5, CTSS) have been linked to risk of MS and the response to treatment with immunomodulators. This research aims to estimate the risk that confers some variations in the sequence of these genes.

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.

Detailed Description:

Genes HLA-DRB1 * and some genes involved in inflammation and immunity have been linked to risk of MS and the response to treatment with immunomodulators.

The HLA-DRB1 * genes have been associated with risk and response to treatment in MS in multiple studies; however, other genes have been controversial. This research aims to estimate the risk for MS that confers some variations in the sequence of IL-7R, GPC5, CTSS, HLA-DRB1 genes. Furthermore, it seeks to determine whether these gene variants (polymorphisms) are associated with treatment response to immunomodulators.

Subjects with MS and healthy subjects will be taken to assess the risk for MS. Besides the investigators obtain the medical history of relapse to assess response to treatment in accordance with Expanded Disability Status Scale (EDSS) and relapses.


Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association of Polymorphisms of the Interleukin-7 Receptor-α (IL-7R), Glypican 5 (GPC5), Interleukin-2 Receptor-α (IL2-RA) , Human Leukocyte Antigen Class II Beta Chain (HLA-DRB1) Genes and Treatment Response in Multiple Sclerosis (MS).
Study Start Date : August 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases
Subjects with Relapsing-Remitting Multiple Sclerosis. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.
Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.
The frequencies of the polymorphic variants in subjects with MS and healthy subjects were evaluated. Also in subjects with MS, the response to treatment with the number of relapses and EDSS was assessed; to compare the allele frequencies of SNPs of Interleukins, Glypican, and Human Leukocyte Antigen Genes, between responders and no responders MS patients.

Controls
Healthy subjects. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.
Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.
The frequencies of the polymorphic variants in subjects with MS and healthy subjects were evaluated. Also in subjects with MS, the response to treatment with the number of relapses and EDSS was assessed; to compare the allele frequencies of SNPs of Interleukins, Glypican, and Human Leukocyte Antigen Genes, between responders and no responders MS patients.

Responders
Subjects with MS treated for at least two years that have less than one relapse per year or who had an increase of <1.5 points on the Expanded Disability Status Scale (EDSS) (if baseline EDSS was 0) or no increase in EDSS (baseline EDSS ≥1). Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.
Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.
The frequencies of the polymorphic variants in subjects with MS and healthy subjects were evaluated. Also in subjects with MS, the response to treatment with the number of relapses and EDSS was assessed; to compare the allele frequencies of SNPs of Interleukins, Glypican, and Human Leukocyte Antigen Genes, between responders and no responders MS patients.

No responders
Subjects with MS that have more than one relapse per year treated for at least two years, and who had ≥1 relapse(s) or an increase of 1.5 points on the EDSS (if baseline EDSS was 0) or an increase of ≥0.5 points (baseline EDSS ≥1). Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.
Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.
The frequencies of the polymorphic variants in subjects with MS and healthy subjects were evaluated. Also in subjects with MS, the response to treatment with the number of relapses and EDSS was assessed; to compare the allele frequencies of SNPs of Interleukins, Glypican, and Human Leukocyte Antigen Genes, between responders and no responders MS patients.




Primary Outcome Measures :
  1. Treatment response evaluated by relapses per year, evaluated during two years after recruitment. [ Time Frame: Two Years ]
    Treatment response evaluated by relapses per year during two years after recruitment. The relapses are defined by any neurological sign or symptom that happens at least 30 days after any previous neurological deterioration episode began.

  2. Treatment response evaluated by Expanded Disability Status Scale (EDSS) during two years after recruitment. [ Time Frame: Two Years ]

    Treatment response evaluated by Expanded Disability Status Scale (EDSS) during two years after recruitment.

    The EDSS scale ranges from 0 to 10; the increments are in 0.5. Scoring is based on an examination by a neurologist about the level of disability.



Secondary Outcome Measures :
  1. Multiple Sclerosis Risk Conferred by Single Nucleotide Polymorphisms (SNPs) of Interleukins, Glypican, and Human Leukocyte Antigen Genes. [ Time Frame: One Year ]
    The risk conferred by SNPs of Interleukins, Glypican, and Human Leukocyte Antigen Genes: calculated by odds ratio when the allele frequencies of SNPs cases are compared with the allele frequencies of SNPs in healthy subjects.


Biospecimen Retention:   Samples With DNA
Total blood for posterior extraction of DNA.


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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:   Probability Sample
Study Population
Subjects with multiple sclerosis and healthy subjects were studied. In subjects with multiple sclerosis, the number of relapses and EDSS was evaluated for two years.
Criteria

Inclusion Criteria for Cases:

  • Subjects with multiple sclerosis
  • 18 and over
  • EDSS less than 5
  • Signed informed consent

Inclusion Criteria for Controls:

  • Healthy subjects
  • 18 and over
  • Signed informed consent

Exclusion Criteria for Cases:

  • Mental retardation
  • Withdrawal of consent
  • No immunomodulatory treatment

Exclusion Criteria for Controls:

  • Mental retardation
  • Withdrawal of consent

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): NCT02769767


Contacts
Contact: JOSE A. CRUZ RAMOS, PhD 0152 3314886313 josealfonsocr@gmail.com
Contact: EMMANUEL DE LA MORA JIMENEZ, PhD 0152 36580556 moraej@hotmail.com

Locations
Mexico
Instituto Jalisciense de Cancerología Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: JOSE A. CRUZ RAMOS, PhD    0152 3314886313    josealfonsocr@gmail.com   
Sponsors and Collaborators
Instituto Jalisciense de Cancerologia
Instituto Mexicano del Seguro Social
University of Guadalajara
Investigators
Principal Investigator: JOSE A. CRUZ RAMOS, PhD Instituto Jalisciense de Cancerología

Responsible Party: Jose Alfonso Cruz-Ramos, Research Coordinator, Instituto Jalisciense de Cancerologia
ClinicalTrials.gov Identifier: NCT02769767     History of Changes
Other Study ID Numbers: EM-1
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases