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

May 10, 2016 updated by: Jose Alfonso Cruz-Ramos, Instituto Jalisciense de Cancerologia

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).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: EMMANUEL DE LA MORA JIMENEZ, PhD
  • Phone Number: 0152 36580556
  • Email: moraej@hotmail.com

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Recruiting
        • Instituto Jalisciense de Cancerologia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Two Years
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.
Two Years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Jalisciense de Cancerologia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Guadalajara
Instituto Mexicano del Seguro Social

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JOSE A. CRUZ RAMOS, PhD, Instituto Jalisciense de Cancerologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EM-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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