Identifying Novel Biomarkers in Early Rheumatology Patients

• Conditions: Rheumatologic Disorder
• Interventions: Other: There is no intervention, but a diagnosis.

• Registration Number: NCT03843658
• Lead Sponsor: Arthritis Northwest PLLC

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.

Detailed Description

At the end of their first visit new rheumatology patients will be asked for their interest in joining the Inova biomarker study. If yes, the patient will be consented, blood will be drawn for the Inova biomarkers, and x-rays will be sent for sharp scoring. Patients may decline and will not be part of the Inova study. Patients who decline will continue to receive standard of care treatment henceforth.

Patients in the Inova trial will receive a diagnosis from their doctor and are placed into separate cohorts based upon their diagnosis. The Inova biomarker results of each cohort will be cross-correlated with diagnoses, pre-screening tool results. Baseline disease activity and sharp scores will also be correlation variables.

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-14
• Last Update Submitted: 2019-02-14
• Study First Posted: 2019-02-18
• Last Update Posted: 2019-02-18
• Study Start: 2019-03-15
• Primary Completion: 2020-03-15
• Study Completion: 2020-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Newly referred Arthritis Northwest PLLC
• Age 18 or older

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid Arthritis	There is no intervention, but a diagnosis.	Clinician diagnosed rheumatoid arthritis
Non-Inflammatory arthritis	There is no intervention, but a diagnosis.	E.g. Osteoarthritis and Fibromyalgia
Crystalline arthritis	There is no intervention, but a diagnosis.	Gout and Pseudo gout
Spondyloarthropathy	There is no intervention, but a diagnosis.	Ankylosing spondylitis and psoriatic arthritis
Connective Tissue Disease	There is no intervention, but a diagnosis.	Lupus, myositis, scleroderma, and sjogren's

Primary Outcome Measures

Name	Time	Method
The correlation between novel biomarkers and the primary rheumatology diagnosis	18 month enrollment period. No follow-up period	Pearson's correlation coefficient of each biomarker to each cohort