DNA Methylation in PMR

NCT07748195 | Not Yet Recruiting

• 1 other identifier: 02003035
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Polymyalgia Rheumatica (PMR)

Outcome Measures

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.

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Polymyalgia Rheumatica

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Vivekanand Tiwai, MD

CONTACT

(603) 650-8622; vivekanand.tiwari@hitchcock.org

Olivia Brooker, BS

CONTACT

(603) 650-8622; olivia.f.brooker@hitchcock.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Staff Rheumatologist

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: August 5, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share