Identifying Novel Biomarkers in Early Rheumatology Patients

February 14, 2019 updated by: Arthritis Northwest PLLC
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 18 month enrollment period. No follow-up period
Pearson's correlation coefficient of each biomarker to each cohort
18 month enrollment period. No follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthritis Northwest PLLC

Collaborators

Bristol-Myers Squibb
University of Nebraska
Inova Diagnostics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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