DNA Methylation in PMR | NCT07748195

NCT07748195

Overview

NCT ID: NCT07748195
Lead Sponsor: Dartmouth-Hitchcock Medical CenterOTHER
Official Title: DNA Methylation in PMR
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Jul 20, 2026Estimated
Primary Completion Date: Apr 1, 2027Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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:

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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 50Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: Vivekanand Tiwai, MDContact
vivekanand.tiwari@hitchcock.org

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