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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03190746
Other study ID # FKE 20150004H
Secondary ID
Status Completed
Phase N/A
First received June 11, 2017
Last updated June 14, 2017
Start date June 1, 2015
Est. completion date June 1, 2017

Study information

Verified date June 2017
Source Keesler Air Force Base Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date June 1, 2017
Est. primary completion date June 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
TaqMan SNP analysis
TaqMan SNP analysis of the YWHAH gene

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Keesler Air Force Base Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Relationship to RA disease severity 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). 2.5 years
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