Identifying Novel Biomarkers in Early Rheumatology Patients

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatologic Disorder
• Intervention / Treatment: Other: There is no intervention, but a diagnosis.

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Terri Cone; Phone Number: 5098386500; Email: tcone@arthritisnw.com
• Study Contact Backup: Name: Bonnie Burgess; Phone Number: 5098386500; Email: bburgess@arthritisnw.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Newly referred Arthritis Northwest PLLC
• Age 18 or older

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rheumatoid Arthritis; Clinician diagnosed rheumatoid arthritis	Other: There is no intervention, but a diagnosis.; Cohorts will be determined by the primary rheumatology diagnosis.
Spondyloarthropathy; Ankylosing spondylitis and psoriatic arthritis	Other: There is no intervention, but a diagnosis.; Cohorts will be determined by the primary rheumatology diagnosis.
Crystalline arthritis; Gout and Pseudo gout	Other: There is no intervention, but a diagnosis.; Cohorts will be determined by the primary rheumatology diagnosis.
Connective Tissue Disease; Lupus, myositis, scleroderma, and sjogren's	Other: There is no intervention, but a diagnosis.; Cohorts will be determined by the primary rheumatology diagnosis.
Non-Inflammatory arthritis; E.g. Osteoarthritis and Fibromyalgia	Other: There is no intervention, but a diagnosis.; Cohorts will be determined by the primary rheumatology diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Arthritis Northwest PLLC
• Collaborators: Bristol-Myers Squibb; University of Nebraska; Inova Diagnostics Inc

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2019
• Primary Completion (Anticipated): March 15, 2020
• Study Completion (Anticipated): September 15, 2020

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: R-18002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No