Polymorphisms of Interleukins, Glypican, and Human Leukocyte Antigen Genes and Treatment Response in Multiple Sclerosis.
WESTEMDRB1
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).
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
May 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 12, 2016
May 1, 2016
4.3 years
April 25, 2016
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment response evaluated by relapses per year, evaluated during two years after recruitment.
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.
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 Outcomes (1)
Multiple Sclerosis Risk Conferred by Single Nucleotide Polymorphisms (SNPs) of Interleukins, Glypican, and Human Leukocyte Antigen Genes.
One Year
Study Arms (4)
Cases
Subjects with Relapsing-Remitting Multiple Sclerosis. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.
Controls
Healthy subjects. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Subjects with multiple sclerosis
- and over
- EDSS less than 5
- Signed informed consent
- Healthy subjects
- and over
- Signed informed consent
You may not qualify if:
- Mental retardation
- Withdrawal of consent
- No immunomodulatory treatment
- Mental retardation
- Withdrawal of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Instituto Jalisciense de Cancerologialead
- Instituto Mexicano del Seguro Socialcollaborator
- University of Guadalajaracollaborator
Study Sites (1)
Instituto Jalisciense de Cancerología
Guadalajara, Jalisco, 44280, Mexico
Biospecimen
Total blood for posterior extraction of DNA.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JOSE A. CRUZ RAMOS, PhD
Instituto Jalisciense de Cancerología
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Coordinator
Study Record Dates
First Submitted
April 25, 2016
First Posted
May 12, 2016
Study Start
August 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
May 12, 2016
Record last verified: 2016-05