Identifying Novel Biomarkers in Early Rheumatology Patients

NCT ID: NCT03843658

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2020-09-15

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.

Conditions

Rheumatologic Disorder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Rheumatoid Arthritis

Clinician diagnosed rheumatoid arthritis

There is no intervention, but a diagnosis.

Intervention Type: OTHER

Cohorts will be determined by the primary rheumatology diagnosis.

Spondyloarthropathy

Ankylosing spondylitis and psoriatic arthritis

There is no intervention, but a diagnosis.

Intervention Type: OTHER

Cohorts will be determined by the primary rheumatology diagnosis.

Crystalline arthritis

Gout and Pseudo gout

There is no intervention, but a diagnosis.

Intervention Type: OTHER

Cohorts will be determined by the primary rheumatology diagnosis.

Connective Tissue Disease

Lupus, myositis, scleroderma, and sjogren's

There is no intervention, but a diagnosis.

Intervention Type: OTHER

Cohorts will be determined by the primary rheumatology diagnosis.

Non-Inflammatory arthritis

E.g. Osteoarthritis and Fibromyalgia

There is no intervention, but a diagnosis.

Intervention Type: OTHER

Cohorts will be determined by the primary rheumatology diagnosis.

Interventions

There is no intervention, but a diagnosis.

Cohorts will be determined by the primary rheumatology diagnosis.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Newly referred Arthritis Northwest PLLC
• Age 18 or older

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inova Diagnostics Inc

UNKNOWN

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: collaborator

Arthritis Northwest PLLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Terri Cone

Role: CONTACT

tcone@arthritisnw.com

5098386500

Bonnie Burgess

Role: CONTACT

bburgess@arthritisnw.com

5098386500

Other Identifiers

R-18002

Identifier Type: -

Identifier Source: org_study_id