NCT03843658

Brief Summary

Patients new to a rheumatology practice will be asked if they want to consent to their blood sample, medical records, and hand/foot x-rays (with sharp scores) for the analysis and correlation with the diagnosis they will receive from the rheumatologist.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Status
unknown

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

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 14, 2019

Last Update Submit

February 14, 2019

Conditions

Rheumatologic Disorder

Outcome Measures

Primary Outcomes (1)

  • The correlation between novel biomarkers and the primary rheumatology diagnosis

    Pearson's correlation coefficient of each biomarker to each cohort

    18 month enrollment period. No follow-up period

Study Arms (5)

Rheumatoid Arthritis

Clinician diagnosed rheumatoid arthritis

Other: There is no intervention, but a diagnosis.

Spondyloarthropathy

Ankylosing spondylitis and psoriatic arthritis

Other: There is no intervention, but a diagnosis.

Crystalline arthritis

Gout and Pseudo gout

Other: There is no intervention, but a diagnosis.

Connective Tissue Disease

Lupus, myositis, scleroderma, and sjogren's

Other: There is no intervention, but a diagnosis.

Non-Inflammatory arthritis

E.g. Osteoarthritis and Fibromyalgia

Other: There is no intervention, but a diagnosis.

Interventions

There is no intervention, but a diagnosis.OTHER

Cohorts will be determined by the primary rheumatology diagnosis.

Connective Tissue DiseaseCrystalline arthritisNon-Inflammatory arthritisRheumatoid ArthritisSpondyloarthropathy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All newly referred adults to Arthritis Northwest PLLC will be offered the opportunity to enroll in the study.

You may qualify if:

  • Newly referred Arthritis Northwest PLLC
  • Age 18 or older

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Collagen Diseases

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Terri Cone

CONTACT

5098386500tcone@arthritisnw.com

Bonnie Burgess

CONTACT

5098386500bburgess@arthritisnw.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Study Start

March 15, 2019

Primary Completion

March 15, 2020

Study Completion

September 15, 2020

Last Updated

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share