Clinical trial NCT02769767: Polymorphisms of Interleukins, Glypican, and Human Leukocyte Antigen Genes and Treatment Response in Multiple Sclerosis.
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Instituto Jalisciense de Cancerologia
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Mexicano del Seguro Social
name: University of Guadalajara
First posted: 2016-05-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Treatment response evaluated by relapses per year, evaluated during two years after recruitment.
timeFrame: Two Years
measure: Treatment response evaluated by Expanded Disability Status Scale (EDSS) during two years after recruitment.
timeFrame: Two Years
Secondary outcomes:
measure: Multiple Sclerosis Risk Conferred by Single Nucleotide Polymorphisms (SNPs) of Interleukins, Glypican, and Human Leukocyte Antigen Genes.
timeFrame: One Year
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Cancerología
state: Jalisco
Study officials:
affiliation: Instituto Jalisciense de Cancerología
name: JOSE A. CRUZ RAMOS, PhD
role: PRINCIPAL_INVESTIGATOR
References: