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Relationship of YWHAH Polymorphisms to Rheumatoid Arthritis Disease Severity

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ClinicalTrials.gov Identifier: NCT03190746
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Keesler Air Force Base Medical Center

Brief Summary:
It is hypothesized that one or several of these 6 single nucleotide polymorphisms (SNPs) (rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226) in the YWHAH gene could be related to RA disease severity.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Diagnostic Test: TaqMan SNP analysis

Detailed Description:

Rheumatoid Arthritis (RA) is a chronic inflammatory arthritis of substantial morbidity. Serum biomarkers such as Rheumatoid Factor and anti-cyclic citrullinated peptide assist with disease diagnosis and prognostic assessment of future disease activity. 14-3-3 eta is a relatively new RA serum biomarker. The 14-3-3 family of proteins were named based on chromatographic elution properites and are ubiquitously expressed intracellular chaperon proteins. The isoform relevant in RA is 14-3-3 eta. 14-3-3 eta provides additional information about RA to the clinician-it assists in making diagnosis, provides prognostic assessment of disease severity, and provides insight regarding response to therapy. Thus, 14-3-3 eta serves as an important mechanistic biomarker informing the clinician about patient's RA.

14-3-3 eta is the product of the YWHAH gene, located on chromosome 22q12.3. It is about 13 kilobase long, consisting of two exons separated by a single intron. This gene has been implicated in linkage studies to bipolar disorder and schizophrenia. Six YWHAH single nucleotide polymorphisms (SNPs) were identified in a prior study: rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226. rs2246704 was associated with bipolar disorder (Odds Ratio (OR) 1.31, p=0.03) and psychotic BP (OR 1.66, p=0.002). All six SNPs are intronic. It was hypothesized that one or several of these 6 single nucleotide polymorphisms (SNPs) could be related to RA disease severity.

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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Relationship of YWHAH Polymorphisms to Rheumatoid Arthritis Disease Severity
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
No SNP
Subjects have two copies of the wild type gene
Diagnostic Test: TaqMan SNP analysis
TaqMan SNP analysis of the YWHAH gene

SNP present
Subjects have one or two copies of the SNP
Diagnostic Test: TaqMan SNP analysis
TaqMan SNP analysis of the YWHAH gene




Primary Outcome Measures :
  1. Relationship to RA disease severity [ Time Frame: 2.5 years ]
    The primary endpoint was the relationship of the six YWHAH SNPs to RA disease severity as based on the presence (1 point) or absence (0 points) across several domains: (A) serologic status (positive anti-CCP = 1 point, for example), (b) erosive changes (presence of erosions = 1 point), and (c) extra-articular manifestations (presence = 1 point).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RA patients at an academic medical center
Criteria

Inclusion Criteria:

  • Have RA per 1987 or 2010 American College of Rheumatology Classification Criteria

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190746


Sponsors and Collaborators
Keesler Air Force Base Medical Center
Investigators
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Study Chair: Thomas Shaak, PhD Research Director
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Responsible Party: Keesler Air Force Base Medical Center
ClinicalTrials.gov Identifier: NCT03190746    
Other Study ID Numbers: FKE 20150004H
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Small pilot trial with limited data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases