ClinicalTrials.gg
Not yet recruitingNCT07748195Updated Aug 26, 2026

DNA Methylation in PMR

An observational study in Polymyalgia Rheumatica (PMR), sponsored by Dartmouth-Hitchcock Medical Center. Not yet recruiting. Open to participants aged 50 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Dartmouth-Hitchcock Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
50 Years to 89 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Polymyalgia Rheumatica (PMR)

Browse trials for

03

In context

Polymyalgia Rheumatica

68 studies on the registry are indexed under Polymyalgia Rheumatica; 22 are open to participants now.

This study's planned enrollment of 50 is below the median of 133 across 27 observational studies indexed under Polymyalgia Rheumatica.

Browse Polymyalgia Rheumatica studies →

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who are seen in DHMC's PMR clinic and have a PMR diagnosis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of concomitant Giant cell arteritis (GCA) any other rheumatological disorders like lupus, arthritis (psoriatic, osteo), scleroderma, sjogrens Active - 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
4 Weeks
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07748195
Responsible party
Vivekanand.Tiwari (Assistant Professor of Medicine, Staff Rheumatologist, Dartmouth-Hitchcock Medical Center) — Principal investigator
First posted
Aug 5, 2026
Start date
Aug 31, 2026 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Vivekanand Tiwai, MD
Contact
vivekanand.tiwari@hitchcock.org
(603) 650-8622
Olivia Brooker, BS
Contact
olivia.f.brooker@hitchcock.org
(603) 650-8622

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion