Polymyalgia Rheumatica (PMR)NCT07748195
DNA Methylation in PMR
An observational study of Polymyalgia Rheumatica (PMR), run by Dartmouth-Hitchcock Medical Center.
Trial summary
Polymyalgia Rheumatica (PMR) is treated with corticosteroids; however, long-term treatment is not feasible due to side effects. Withdrawal of corticosteroids causes a subset of patients to relapse, and there is no current way to understand what underlies this. Read more about this study
- Who is it for?
- Ages 50 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Polymyalgia Rheumatica (PMR)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 1 Apr 2027
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are seen in DHMC's PMR clinic and have a PMR diagnosis.
Who may be able to join
- Anyone ≥50-89 years old Taking ≥10mg of prednisone or prednisone equivalent at time of enrollment with a stable disease normal ESR and CRP (inflammation markers) which would indicate presence of inflammation or not
- CRP: <1.0 mg/dL (some labs report in mg/L → normal is usually <3 mg/L)
- ESR:
- Men ≥50 years: 0-20 mm/hr
- Women ≥50 years: 0-30 mm/hr Have a PMR diagnosis Able to provide written consent
Who cannot join
- History of concomitant Giant cell arteritis (GCA) any other rheumatological disorders like lupus, arthritis (psoriatic, osteo), scleroderma, sjogrens Active malignancy- presence of tumor by imaging or labs Infection- infection can cause increased levels of innate immune cells making it difficult to differentiate between disease and infection recent surgery- within the past 6 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Polymyalgia Rheumatica (PMR) is treated with corticosteroids; however, long-term treatment is not feasible due to side effects. Withdrawal of corticosteroids causes a subset of patients to relapse, and there is no current way to understand what underlies this. Our research team has preliminary data from a small clinical study that indicates that different immune effector dynamics during the tapering of steroids correlate with relapse. This was achieved using the DNA methylation-specific immune cell profiling methods that Dr. Christensen has pioneered. What is proposed is a larger prospective study of 50 PMR patients to validate differences in CD4 and CD8 memory cells as a predictor of relapse. Finally, we also focus on the Glucocorticoid Methylation Index (GCMI), which is a collection of 28 CpG islands that are methylated in response to corticosteroids. This will allow our team to determine the predictive power of the GCMI for PMR.
- Conditions
- Polymyalgia Rheumatica (PMR)
- Medical subject headings
- Polymyalgia Rheumatica
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 |
|---|---|---|
| PMR diagnosed | individuals who have a PMR diagnosis | |
| Healthy Volunteers | Healthy individuals, without a PMR diagnosis, which will allow age and sex matches with the PMR diagnosed cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding what the exact triggers for immune activation, the specific antigens involved, and the mechanisms underlying disease relapses and glucocorticoid resistance
DNA methylation cytometry is a novel DNA-based cell typing technology that can quantify changes in blood immune cells. The methylation cytometry approach allows for an in-depth insight into 12 immune cell populations (and over 50 immune profile variables) that is not feasible with standard clinical labs. It is both far more affordable and less labor-intensive than flow cytometry, as well as much less logistically complex because it is DNA-based and does not require intact cell membranes.14 Blood can be collected as part of the standard-of-care draw and immediately frozen for later use. DNA methylation analysis is a novel approach to understanding the immunologic underpinnings of PMR pathogenesis and treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia Rheumatica (PMR)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivekanand.Tiwari, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748195
- Sponsor's protocol ID
- 02003035
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 26 Aug 2026
- Results posted
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Methylation in PMR
- ClinicalTrials.gov ID
- NCT07748195
- Acronym / sponsor ID
- 02003035
- Conditions
- Polymyalgia Rheumatica (PMR)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 5 Aug 2026 (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.
Polymyalgia Rheumatica (PMR) is treated with corticosteroids; however, long-term treatment is not feasible due to side effects. Withdrawal of corticosteroids causes a subset of patients to relapse, and there is no current way to understand what underlies this. Our research team has preliminary data from a small clinical study that indicates that different immune effector dynamics during the tapering of steroids correlate with relapse. This was achieved using the DNA methylation-specific immune cell profiling methods that Dr. Christensen has pioneered. What is proposed is a larger prospective study of 50 PMR patients to validate differences in CD4 and CD8 memory cells as a predictor of relapse. Finally, we also focus on the Glucocorticoid Methylation Index (GCMI), which is a collection of 28 CpG islands that are methylated in response to corticosteroids. This will allow our team to determine the predictive power of the GCMI for PMR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMR diagnosed | – | –individuals who have a PMR diagnosis |
| Healthy Volunteers | – | –Healthy individuals, without a PMR diagnosis, which will allow age and sex matches with the PMR diagnosed cohort. |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are seen in DHMC's PMR clinic and have a PMR diagnosis.
Key inclusion criteria (5 listed)
- Anyone ≥50-89 years old Taking ≥10mg of prednisone or prednisone equivalent at time of enrollment with a stable disease normal ESR and CRP (inflammation markers) which would indicate presence of inflammation or not
- CRP: <1.0 mg/dL (some labs report in mg/L → normal is usually <3 mg/L)
- ESR:
- Men ≥50 years: 0-20 mm/hr
- Women ≥50 years: 0-30 mm/hr Have a PMR diagnosis Able to provide written consent
Key exclusion criteria (1 listed)
- History of concomitant Giant cell arteritis (GCA) any other rheumatological disorders like lupus, arthritis (psoriatic, osteo), scleroderma, sjogrens Active malignancy- presence of tumor by imaging or labs Infection- infection can cause increased levels of innate immune cells making it difficult to differentiate between disease and infection recent surgery- within the past 6 months
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
Understanding what the exact triggers for immune activation, the specific antigens involved, and the mechanisms underlying disease relapses and glucocorticoid resistance
Time frame: 12 months
DNA methylation cytometry is a novel DNA-based cell typing technology that can quantify changes in blood immune cells. The methylation cytometry approach allows for an in-depth insight into 12 immune cell populations (and over 50 immune profile variables) that is not feasible with standard clinical labs. It is both far more affordable and less labor-intensive than flow cytometry, as well as much less logistically complex because it is DNA-based and does not require intact cell membranes.14 Blood can be collected as part of the standard-of-care draw and immediately frozen for later use. DNA methylation analysis is a novel approach to understanding the immunologic underpinnings of PMR pathogenesis and treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymyalgia Rheumatica (PMR), run by Dartmouth-Hitchcock Medical Center.
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 5 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: opening soon, as of the sponsor's last update on 26 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivekanand Tiwai, MD ((603) 650-8622, vivekanand.tiwari@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding what the exact triggers for immune activation, the specific antigens involved, and the mechanisms underlying disease relapses and glucocorticoid resistance (time frame: 12 months). 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 26 Aug 2026.