Rheumatologic DisorderNCT03843658
Identifying Novel Biomarkers in Early Rheumatology Patients
An observational study of Rheumatologic Disorder, run by Arthritis Northwest PLLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatologic Disorder
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2019to 15 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All newly referred adults to Arthritis Northwest PLLC will be offered the opportunity to enroll in the study.
Who may be able to join
- Newly referred Arthritis Northwest PLLC
- Age 18 or older
Who cannot join
- None.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- There is no intervention, but a diagnosis.
- Medical subject headings
- Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention, but a diagnosis.Other
Cohorts will be determined by the primary rheumatology diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | Clinician diagnosed rheumatoid arthritis Receives: Other: There is no intervention, but a diagnosis. | |
| Spondyloarthropathy | Ankylosing spondylitis and psoriatic arthritis Receives: Other: There is no intervention, but a diagnosis. | |
| Crystalline arthritis | Gout and Pseudo gout Receives: Other: There is no intervention, but a diagnosis. | |
| Connective Tissue Disease | Lupus, myositis, scleroderma, and sjogren's Receives: Other: There is no intervention, but a diagnosis. | |
| Non-Inflammatory arthritis | E.g. Osteoarthritis and Fibromyalgia Receives: Other: There is no intervention, but a diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between novel biomarkers and the primary rheumatology diagnosis
Pearson's correlation coefficient of each biomarker to each cohort
Measured: 18 month enrollment period. No follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start15 Mar 2019 (estimated)
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthritis Northwest PLLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inova Diagnostics Inc, Bristol-Myers Squibb, University of Nebraska
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843658
- Sponsor's protocol ID
- R-18002
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Novel Biomarkers in Early Rheumatology Patients
- ClinicalTrials.gov ID
- NCT03843658
- Acronym / sponsor ID
- R-18002
- Conditions
- Rheumatologic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Arthritis Northwest PLLCIndustry (pharma, biotech, devices)
- Collaborators
- Inova Diagnostics Inc, Bristol-Myers Squibb, University of Nebraska
- Study start
- 15 Mar 2019 (estimated)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | Other: There is no intervention, but a diagnosis.Clinician diagnosed rheumatoid arthritis |
| Spondyloarthropathy | – | Other: There is no intervention, but a diagnosis.Ankylosing spondylitis and psoriatic arthritis |
| Crystalline arthritis | – | Other: There is no intervention, but a diagnosis.Gout and Pseudo gout |
| Connective Tissue Disease | – | Other: There is no intervention, but a diagnosis.Lupus, myositis, scleroderma, and sjogren's |
| Non-Inflammatory arthritis | – | Other: There is no intervention, but a diagnosis.E.g. Osteoarthritis and Fibromyalgia |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All newly referred adults to Arthritis Northwest PLLC will be offered the opportunity to enroll in the study.
Key inclusion criteria (2 listed)
- Newly referred Arthritis Northwest PLLC
- Age 18 or older
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention, but a diagnosis.Cohorts will be determined by the primary rheumatology diagnosis. | Other | Connective Tissue Disease, Crystalline arthritis, Non-Inflammatory arthritis, Rheumatoid Arthritis, Spondyloarthropathy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatologic Disorder, run by Arthritis Northwest PLLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Terri Cone (5098386500, tcone@arthritisnw.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between novel biomarkers and the primary rheumatology diagnosis (time frame: 18 month enrollment period. No follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.