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

Instituto Jalisciense de Cancerologia

Status: Unknown

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.

Study type: Observational

Funder types: Other

Identifiers

NCT02769767

EM-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

500 participants in 4 patient groups

Cases

Description:

Subjects with Relapsing-Remitting Multiple Sclerosis. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.

Treatment:

Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.

Controls

Description:

Healthy subjects. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.

Treatment:

Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.

Responders

Description:

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.

Treatment:

Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.

No responders

Description:

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.

Treatment:

Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.