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

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.

• Registration Number: NCT02769767
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2016-04-25
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-10
• Last Update Submitted: 2016-05-10
• Study First Posted: 2016-05-12
• Last Update Posted: 2016-05-12
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No responders	Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.	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.
Controls	Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.	Healthy subjects. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.
Responders	Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.	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.
Cases	Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.	Subjects with Relapsing-Remitting Multiple Sclerosis. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.

Primary Outcome Measures

Name	Time	Method
Treatment response evaluated by relapses per year, evaluated during two years after recruitment.	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.
Treatment response evaluated by Expanded Disability Status Scale (EDSS) during two years after recruitment.	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

Name	Time	Method
Multiple Sclerosis Risk Conferred by Single Nucleotide Polymorphisms (SNPs) of Interleukins, Glypican, and Human Leukocyte Antigen Genes.	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.

Trial Locations

Locations (1)

Instituto Jalisciense de Cancerología; 🇲🇽 Guadalajara, Jalisco, Mexico