NCT03190746

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

June 11, 2017

Last Update Submit

June 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

No SNP

Subjects have two copies of the wild type gene

Diagnostic Test: TaqMan SNP analysis

SNP present

Subjects have one or two copies of the SNP

Diagnostic Test: TaqMan SNP analysis

Interventions

TaqMan SNP analysisDIAGNOSTIC_TEST

TaqMan SNP analysis of the YWHAH gene

No SNPSNP present

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

RA patients at an academic medical center

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Thomas Shaak, PhD

    Research Director

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2017

First Posted

June 19, 2017

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 19, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Small pilot trial with limited data