NCT04226131: MusculRA

MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics

Completed NA Last updated 13 July 2023

What this trial tests

NA trial testing Blood Draw in Rheumatoid Arthritis in 21 participants. Completed in 7 July 2023.

Timeline

9 September 2020

Primary endpoint
7 July 2023

7 July 2023

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	21
Start date	9 September 2020
Primary completion	7 July 2023
Estimated completion	7 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Blood Draw — full drug profile →
• Disease Activity (DAS-28) Assessment
• Skeletal Muscle Mitochondrial Respiratory Capacity
• Muscle Biopsy
• Body Composition
• Cardiopulmonary Exercise Test (CPET)
• Strength Testing
• Questionnaires
• Skeletal Muscle Biomechanical Property Assessment

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
• Healthy Controls — all drugs for Healthy Controls →

Sponsor

Duke University

Who can join

Adults 25 to 75, any sex, with Rheumatoid Arthritis or Healthy Controls. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Persons with rheumatoid arthritis (RA) suffer from increased disability and mortality, in part resulting from skeletal muscle impairments. In this study, our objective is to determine if skeletal muscle biomechanical properties are altered in RA. Up to 15 participants with early RA defined as duration of disease/symptoms of less than 6 months (where "duration" denotes the length of time the patient has had symptoms/disease, not the length of time since RA diagnosis) AND prior to starting biologic Disease-modifying anti-rheumatic drugs (bDMARD) therapy and 15 age-, sex-, and BMI-matched controls will undergo clinical assessments of skeletal muscle stiffness and elasticity as measured by the hand-held MyotonPro device. Additional study participant assessments include cardiopulmonary exercise testing, muscle strength testing, body composition measurement using BodPod, muscle oxidative capacity testing using near-infrared spectroscopy, and thigh muscle needle biopsies to compare clinical findings to an ex vivo cultured myobundle system. Primary statistical analyses will be comparisons of skeletal muscle parameters in RA compared to controls and correlations to determine relationships between variables. Thigh muscle biopsies are a low-risk procedure that may cause minor local soreness and bleeding; all other clinical assessments are non-invasive and will induce minimal discomfort to participants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immunoglobulin G and plasma glycome in early rheumatoid arthritis differ from matched controls and link less fat-free mass to an accelerated aging phenotype: an exploratory study.
   Hashmi SW, Andonian BJ, Thompson MM, Bennett WC, et al · · 2026 · PMID 42015271 · DOI 10.1186/s13075-026-03818-6