Arthritis, RheumatoidNCT02742337
Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease
An observational study of Arthritis, Rheumatoid, run by Arthritis Northwest PLLC at 1 site in United States.
Trial summary
Given the cost and risk associated with biologic disease modifying anti-rheumatic drugs (bDMARDs), selection of the optimal medication is imperative. Current attempts to identify genetic factors that predict bDMARD response and effectiveness in rheumatoid arthritis patients have been inconclusive. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 2016
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is at-risk patients for chronic auto-immune and rheumatic disease.
Who may be able to join
None listed.
Who cannot join
- Male
- Age 17 or less
- History of Disease Modifying Anti-Rheumatic Drugs (DMARDs), or biologic DMARDs.
- History of malignancy, except non-melanoma skin cancer
- Previous treatment for malignancy with chemotherapy agents
- Patient reported history of HIV, HepB, HepC, or TB
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arthritis Northwest
Spokane, Washington, 99208
Keith D Knapp, Ph.D., 509-838-6500 ext. 336, kknapp@arthritisnw.com
Keith D Knapp, Ph.D.
About this study
- Given the cost and risk associated with biologic disease modifying anti-rheumatic drugs (bDMARDs), selection of the optimal medication is imperative. Current attempts to identify genetic factors that predict bDMARD response and effectiveness in rheumatoid arthritis patients have been inconclusive. Furthermore the presence of epigenetic signatures in rheumatoid arthritis patients has not been established. This protocol is the first step to identifying the practicality and feasibility of epigenetic testing to aid in diagnosis and/or medication selection in rheumatoid arthritis patients. Subsequent research into such epigenetic changes may be indicative of bDMARD response and/or safety. If such epigenetic signatures (EGS) exist the business need for such tests will thus be supported.
Read the detailed description
Two groups of patients will be assessed for the presence unique epigenetic signatures. The test group, having a bonafide diagnosis of rheumatoid arthritis (RA) and a control group of subjects who does not fulfill the American College of Rheumatology's classification criteria for RA. A buccal cell sample and blood draw will be sequenced and analyzed from each subject in each group for the presence of epigenetic signatures.
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Epigenetic
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Test | Newly diagnosed female patients with rheumatoid arthritis who have not previously used a disease modifying anti-rheumatic drug. | |
| Control | Female patients not having a diagnosis of rheumatoid arthritis and who have not previously used a disease modifying anti-rheumatic drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counts of patients with epigenetic signatures.
The identification of a statistically significant number of RA patients having a consistent epigenetic signature
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthritis Northwest PLLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Epigenesys LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742337
- Sponsor's protocol ID
- AE010831
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2016
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease
- ClinicalTrials.gov ID
- NCT02742337
- Acronym / sponsor ID
- AE010831
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Epigenetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Arthritis Northwest PLLCIndustry (pharma, biotech, devices)
- Collaborators
- Epigenesys LLC
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- 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.
- Given the cost and risk associated with biologic disease modifying anti-rheumatic drugs (bDMARDs), selection of the optimal medication is imperative. Current attempts to identify genetic factors that predict bDMARD response and effectiveness in rheumatoid arthritis patients have been inconclusive. Furthermore the presence of epigenetic signatures in rheumatoid arthritis patients has not been established. This protocol is the first step to identifying the practicality and feasibility of epigenetic testing to aid in diagnosis and/or medication selection in rheumatoid arthritis patients. Subsequent research into such epigenetic changes may be indicative of bDMARD response and/or safety. If such epigenetic signatures (EGS) exist the business need for such tests will thus be supported.
Detailed description
Two groups of patients will be assessed for the presence unique epigenetic signatures. The test group, having a bonafide diagnosis of rheumatoid arthritis (RA) and a control group of subjects who does not fulfill the American College of Rheumatology's classification criteria for RA. A buccal cell sample and blood draw will be sequenced and analyzed from each subject in each group for the presence of epigenetic signatures.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | – | –Newly diagnosed female patients with rheumatoid arthritis who have not previously used a disease modifying anti-rheumatic drug. |
| Control | – | –Female patients not having a diagnosis of rheumatoid arthritis and who have not previously used a disease modifying anti-rheumatic drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is at-risk patients for chronic auto-immune and rheumatic disease.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Male
- Age 17 or less
- History of Disease Modifying Anti-Rheumatic Drugs (DMARDs), or biologic DMARDs.
- History of malignancy, except non-melanoma skin cancer
- Previous treatment for malignancy with chemotherapy agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Counts of patients with epigenetic signatures.
Time frame: 1 day
The identification of a statistically significant number of RA patients having a consistent epigenetic signature
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Arthritis Northwest PLLC at 1 site in United States.
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 0 inclusion and 6 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Gary L Craig, MD (5098386500, gcraig@arthritisnw.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Counts of patients with epigenetic signatures. (time frame: 1 day). 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 19 Apr 2016.