Multiple Sclerosis, Relapsing-RemittingWESTEMDRB1NCT02769767
Polymorphisms of Interleukins, Glypican, and Human Leukocyte Antigen Genes and Treatment Response in Multiple Sclerosis.
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Instituto Jalisciense de Cancerologia at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.
- How many people
- 500 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Subjects with multiple sclerosis
- 18 and over
- EDSS less than 5
- Signed informed consent
- Healthy subjects
- 18 and over
- Signed informed consent
Who cannot join
- Mental retardation
- Withdrawal of consent
- No immunomodulatory treatment
- Mental retardation
- Withdrawal of consent
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Jalisciense de Cancerología
Guadalajara, Jalisco, 44280
JOSE A. CRUZ RAMOS, PhD, 0152 3314886313, josealfonsocr@gmail.com
About this study
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).
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.Genetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Subjects with Relapsing-Remitting Multiple Sclerosis. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined. Receives: Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes. | |
| Controls | Healthy subjects. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined. Receives: Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes. | |
| 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. Receives: Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes. | |
| 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. Receives: Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two Years
Secondary outcomes (1)
Multiple Sclerosis Risk Conferred by Single Nucleotide Polymorphisms (SNPs) of Interleukins, Glypican, and Human Leukocyte Antigen Genes.
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.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startAug 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Jalisciense de Cancerologia
- Sponsor type
- Other government
- Collaborators
- Instituto Mexicano del Seguro Social, University of Guadalajara
- Responsible party
- Principal investigator, Jose Alfonso Cruz-Ramos, Instituto Jalisciense de Cancerologia
- Investigators
- JOSE A. CRUZ RAMOS, PhD, Principal investigator, Instituto Jalisciense de Cancerología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769767
- Sponsor's protocol ID
- EM-1
- Acronym
- WESTEMDRB1
- Status last verified
- May 2016
- First submitted
- 25 Apr 2016
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02769767
- Acronym / sponsor ID
- WESTEMDRB1 / EM-1
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Instituto Jalisciense de CancerologiaOther government
- Collaborators
- Instituto Mexicano del Seguro Social, University of Guadalajara
- Study start
- Aug 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Genetic: 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. |
| Controls | – | Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.Healthy subjects. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined. |
| Responders | – | Genetic: 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. |
| No responders | – | Genetic: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Subjects with multiple sclerosis
- 18 and over
- EDSS less than 5
- Signed informed consent
- Healthy subjects
Key exclusion criteria (5 listed)
- Mental retardation
- Withdrawal of consent
- No immunomodulatory treatment
- Mental retardation
- Withdrawal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Genetic | Cases, Controls, No responders, Responders |
Primary outcome
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.
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.
1 secondary outcome
Multiple Sclerosis Risk Conferred by Single Nucleotide Polymorphisms (SNPs) of Interleukins, Glypican, and Human Leukocyte Antigen Genes.
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSE A. CRUZ RAMOS, PhD principal investigator
Instituto Jalisciense de Cancerología
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Instituto Jalisciense de Cancerologia at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JOSE A. CRUZ RAMOS, PhD (0152 3314886313, josealfonsocr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response evaluated by relapses per year, evaluated during two years after recruitment. (time frame: Two Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.