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Identifying Novel Biomarkers in Early Rheumatology Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03843658
Recruitment Status : Unknown
Verified February 2019 by Arthritis Northwest PLLC.
Recruitment status was:  Not yet recruiting
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Inova Diagnostics Inc
Bristol-Myers Squibb
University of Nebraska
Information provided by (Responsible Party):
Arthritis Northwest PLLC

Study Description
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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.

Condition or disease Intervention/treatment
Rheumatologic Disorder 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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Identifying Novel Biomarkers in Early Rheumatology Patients
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : September 15, 2020
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Newly referred Arthritis Northwest PLLC
  • Age 18 or older

Exclusion Criteria:

  • None.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843658


Contacts
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Contact: Terri Cone 5098386500 tcone@arthritisnw.com
Contact: Bonnie Burgess 5098386500 bburgess@arthritisnw.com

Sponsors and Collaborators
Arthritis Northwest PLLC
Inova Diagnostics Inc
Bristol-Myers Squibb
University of Nebraska
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Arthritis Northwest PLLC
ClinicalTrials.gov Identifier: NCT03843658    
Other Study ID Numbers: R-18002
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Connective Tissue Diseases
Musculoskeletal Diseases