Relationship of YWHAH Polymorphisms to Rheumatoid Arthritis Disease Severity

Rheumatoid Arthritis Clinical Trial

Official title:

Relationship of YWHAH Polymorphisms to Rheumatoid Arthritis Disease Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190746
• Other study ID #: FKE 20150004H
• 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
• 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:

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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