Rheumatoid ArthritisMusculRANCT04226131
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
A study testing Blood Draw, Disease Activity (DAS-28) Assessment and Skeletal Muscle Mitochondrial Respiratory Capacity in people with Rheumatoid Arthritis and Healthy Controls, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Healthy Controls
- What is being tested?
- Blood Draw, Disease Activity (DAS-28) Assessment and Skeletal Muscle Mitochondrial Respiratory Capacity
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Early RA participants will be excluded if they have already started bDMARD therapy.
- The investigators will exclude persons using non-aspirin anticoagulants that would complicate the biopsy. There will be a wash-out period of seven days for anti-platelet agents, and three days for NSAIDs prior to biopsies.
- Uncontrolled thyroid diseases
- Chronic obstructive lung disease
- Parkinson's disease
- Ankylosing spondylitis
Show all 12Show fewer
- Congestive Heart Failure Class III and above will be excluded based on recognized effects on skeletal muscle.
- Patients with absolute or relative contraindications to exercise will be excluded: recent (<6 months) acute cardiac event, unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism or acute systemic infection, left main coronary stenosis, moderate stenotic valvular heart disease, outflow tract obstruction, high degree atrioventricular (AV) block, ventricular aneurysm.
- Uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxoedema)
- Uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis)
- Mental or physical impairment leading to inability to exercise adequately
- Pregnant women will be excluded as determined via menstrual history/self-reporting.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Living
Durham, North Carolina, 27705
About this study
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.
Read the detailed description
Study design: Up to 30 adults, 25-75 yrs. of age may be recruited and enrolled to participate in a cross-sectional study. Subjects will be divided between two cohorts: 1) persons with early RA (n=15) and 2) age-, sex-, Body Mass Index (BMI)-matched healthy controls (n=15). The goal is to have equal numbers between groups complete the study. 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 DMARD therapy were chosen to minimize the effect of medications on skeletal muscle.
Demographics and comorbidities will be assessed via self-report during an initial phone screening interview, with confirmation from the computerized medical record. Once it has been determined that the subject meets pre-screening criteria, they will be scheduled for Visit-1.
Phone Pre-Screening: Demographics and comorbidities will be assessed via self-report during an initial phone screening interview, with confirmation from the electronic medical record. Once it has been determined that the subject meets pre-screening criteria, they will be scheduled for a virtual study information/consent session.
Online surveys: After completion of the e-consent process, participants will be provided a REDCap survey link via email to complete some online questionnaires about their overall health, pain, fatigue, physical function, sleep and ability to manage their disease.
The study involves two on-site study visits at the Duke Center for Living; each visit lasts approximately 2.5 hours.
Study participants will undergo the following at Visit 1:
- Brief medical history including list of medications
- PROMIS Measures (If unable to complete online prior to Visit-1)
- Anthropometric Measurements: Height/Weight/Body Mass Index
- Vitals: Resting Blood Pressure and Heart Rate
- Fasting Blood Draw
- Physician RA Joint Assessment: Disease Activity (DAS-28) Assessment
- MyotonPro Skeletal Muscle Biomechanical Assessments
- NIRS Muscle Oxidative Capacity Test
- Muscle Biopsy
Brief Medical History and Medication Review: A brief medical history including list of medications will be performed by study staff.
Questionnaires: Using Duke's REDCap (Research Electronic Data Capture) interface, a battery of Patient-Reported Outcomes Measurement Information System (PROMIS) self-reported health outcome measures has been added to a computerized interface and will be associated with this investigation. Measures include global health, pain, fatigue, physical function, self-efficacy for disease management and sleep. Of note, staff testing of this battery indicated this could be completed between 10 and 12 minutes; the investigators project participants may take longer, expecting approximately 30 minutes. Except for global health, scoring is performed by the computerized REDCap interface. Specific measure names and versions as listed in REDCap are listed below:
- PROMIS SF v1.1 Global Health
- PROMIS SF v2.0 Physical Function 20a
- PROMIS Scale v1.0 Pain Intensity 3a
- PROMIS SF v1.0 General Life Satisfaction 5a
- PROMIS Bank v1.0 Short Form Fatigue 8a
- Stanford Brief Activity Survey
Study participants will undergo the following at Visit 2:
- BodPod and Minimal Waist Circumference
- Strength Tests
- Isometric Leg Extension Machine - Quadriceps / Hamstrings Strength
- Hand Dynamometer - Grip Strength
- Cardiopulmonary Exercise Test
- Conditions
- Rheumatoid Arthritis, Healthy Controls
- Being tested
- Blood Draw, Disease Activity (DAS-28) Assessment, Skeletal Muscle Mitochondrial Respiratory Capacity, Muscle Biopsy, Body Composition
- Keywords
- Skeletal Muscle
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
A study nurse will draw up to 150 mL of blood to measure erythrocyte sedimentation rate (ESR) and measures of immune cell function. ESR is a common hematology test that is a measure of inflammation.
Disease Activity (DAS-28) AssessmentOther
Participants in the RA cohort will receive a 28-joint examination by the study physician to assess RA disease activity and report their overall health assessment.
Skeletal Muscle Mitochondrial Respiratory CapacityOther
Also called Near-Infrared Spectroscopy (NIRS)
Near-Infrared Spectroscopy (NIRS) will be used to measure oxidative capacity of forearm flexor digitorum profundus and medial gastrocnemius muscles using the PortaMon device (Artinis Medical Systems, The Netherlands). NIRS is a low-cost, non-invasive method that estimates muscle oxidative capacity by measuring oxygen consumption (mVO2) recovery kinetics via assessment of intramuscular oxy- and deoxy-hemoglobin concentration following a sequence of brief, rapid arterial cuff occlusions. NIRS measures mitochondrial oxidative function as the mVO2 recovery rate constant k. In the absence of blood flow, changes in muscle oxygenation occur via oxygen consumption alone. In persons without RA, this non-invasive approach is highly correlated with muscle respiratory capacity assessed via muscle biopsies using in situ permiabilized fiber bundles and the Oroboros O2k system.
Muscle BiopsyOther
After local anesthesia (xylocaine, 2%) is injected, a small incision will be made in the thigh. Four to six small pieces of muscle about the size of a pea will be surgically removed. The incision site will be closed using steri-strips and/or derma-bond, and a light dressing applied.
Body CompositionOther
Body composition assessments include circumference measurements and the BOD POD®. Minimal waist circumference measurements will be taken using a tape measure.
Cardiopulmonary Exercise Test (CPET)Other
Cardiorespiratory aerobic capacity (VO2 peak), will be assessed using a maximal treadmill test protocol with cardiopulmonary gas exchange. Subjects will be asked to exercise on a treadmill to their perceived maximum ability and effort during which time they will have a mouthpiece in their mouth to determine maximal oxygen use/consumption through breathing. For safety purposes the subject will be monitored by electrocardiogram (ECG) and their blood pressure will be measured at rest and throughout the exercise phase of this test.
Strength TestingOther
Strength assessments will include dynamometry-assessed grip and quadriceps strength (Cybex HUMAC NORM, Comp Sports Med, Inc., Stoughton, MA) tests
QuestionnairesOther
Measures include global health, pain, fatigue, physical function, self-efficacy for disease management and sleep.
Skeletal Muscle Biomechanical Property AssessmentOther
Also called Myotonometry
Passive skeletal muscle stiffness and elasticity measurements of bilateral biceps brachii, flexor carpi radialis, vastus lateralis, and tibialis anterior using mechanical deformation with myotonometry using the MyotonPro device.
| Study group | Role | What they receive |
|---|---|---|
| Early Rheumatoid Arthritis (RA) | Other | 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 Receives: Other: Blood Draw; Other: Disease Activity (DAS-28) Assessment; Other: Skeletal Muscle Mitochondrial Respiratory Capacity; Other: Muscle Biopsy; Other: Body Composition; Other: Cardiopulmonary Exercise Test (CPET); Other: Strength Testing; Other: Questionnaires; Other: Skeletal Muscle Biomechanical Property Assessment |
| Age-, Sex-, BMI-matched Healthy Controls | Other | Healthy Controls. Receives: Other: Blood Draw; Other: Skeletal Muscle Mitochondrial Respiratory Capacity; Other: Muscle Biopsy; Other: Body Composition; Other: Cardiopulmonary Exercise Test (CPET); Other: Strength Testing; Other: Questionnaires; Other: Skeletal Muscle Biomechanical Property Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle stiffness and elasticity
Determine whether passive skeletal muscle stiffness (Newtons/meters) and elasticity (logarithmic decrement) are different in RA compared to matched healthy controls.
Measured: Baseline
Secondary outcomes (2)
Myobundle function
Determine whether myobundle function, including force production and tissue stiffness (kPa), in RA differs compared to controls.
Measured: Baseline
Janus kinase/signal transducers and activators of transcription 3 pathway (JAK/STAT3) signaling in skeletal muscle
Determine whether JAK/STAT3 signaling is upregulated in RA skeletal muscle compared to controls.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start9 Sep 2020
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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 DMARD therapy and 15 age-, sex-, and BMI-matched controls
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Kim M Huffman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226131
- Sponsor's protocol ID
- Pro00103552
- Acronym
- MusculRA
- Status last verified
- Jul 2023
- First submitted
- 9 Jan 2020
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hashmi SW, Andonian BJ, Thompson MM, Bennett WC, Sudnick AM, Johnson JL, Ross LM, Collins-Bennett KA, Belski KB, Vinicki M, Pribic T, Lauc G, Krishnan S, Huffman KM. 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. Arthritis Res Ther. 2026 Apr 21;28(1):123. doi: 10.1186/s13075-026-03818-6.
PubMed 42015271
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
- ClinicalTrials.gov ID
- NCT04226131
- Acronym / sponsor ID
- MusculRA / Pro00103552
- Conditions
- Rheumatoid Arthritis, Healthy Controls
- Keywords
- Skeletal Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 13 Jan 2020 (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.
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.
Detailed description
Study design: Up to 30 adults, 25-75 yrs. of age may be recruited and enrolled to participate in a cross-sectional study. Subjects will be divided between two cohorts: 1) persons with early RA (n=15) and 2) age-, sex-, Body Mass Index (BMI)-matched healthy controls (n=15). The goal is to have equal numbers between groups complete the study. 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 DMARD therapy were chosen to minimize the effect of medications on skeletal muscle.
Demographics and comorbidities will be assessed via self-report during an initial phone screening interview, with confirmation from the computerized medical record. Once it has been determined that the subject meets pre-screening criteria, they will be scheduled for Visit-1.
Phone Pre-Screening: Demographics and comorbidities will be assessed via self-report during an initial phone screening interview, with confirmation from the electronic medical record. Once it has been determined that the subject meets pre-screening criteria, they will be scheduled for a virtual study information/consent session.
Online surveys: After completion of the e-consent process, participants will be provided a REDCap survey link via email to complete some online questionnaires about their overall health, pain, fatigue, physical function, sleep and ability to manage their disease.
The study involves two on-site study visits at the Duke Center for Living; each visit lasts approximately 2.5 hours.
Study participants will undergo the following at Visit 1:
- Brief medical history including list of medications
- PROMIS Measures (If unable to complete online prior to Visit-1)
- Anthropometric Measurements: Height/Weight/Body Mass Index
- Vitals: Resting Blood Pressure and Heart Rate
- Fasting Blood Draw
- Physician RA Joint Assessment: Disease Activity (DAS-28) Assessment
- MyotonPro Skeletal Muscle Biomechanical Assessments
- NIRS Muscle Oxidative Capacity Test
- Muscle Biopsy
Brief Medical History and Medication Review: A brief medical history including list of medications will be performed by study staff.
Questionnaires: Using Duke's REDCap (Research Electronic Data Capture) interface, a battery of Patient-Reported Outcomes Measurement Information System (PROMIS) self-reported health outcome measures has been added to a computerized interface and will be associated with this investigation. Measures include global health, pain, fatigue, physical function, self-efficacy for disease management and sleep. Of note, staff testing of this battery indicated this could be completed between 10 and 12 minutes; the investigators project participants may take longer, expecting approximately 30 minutes. Except for global health, scoring is performed by the computerized REDCap interface. Specific measure names and versions as listed in REDCap are listed below:
- PROMIS SF v1.1 Global Health
- PROMIS SF v2.0 Physical Function 20a
- PROMIS Scale v1.0 Pain Intensity 3a
- PROMIS SF v1.0 General Life Satisfaction 5a
- PROMIS Bank v1.0 Short Form Fatigue 8a
- Stanford Brief Activity Survey
Study participants will undergo the following at Visit 2:
- BodPod and Minimal Waist Circumference
- Strength Tests
- Isometric Leg Extension Machine - Quadriceps / Hamstrings Strength
- Hand Dynamometer - Grip Strength
- Cardiopulmonary Exercise Test
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 DMARD therapy and 15 age-, sex-, and BMI-matched controls
| Arm | Type | Receives |
|---|---|---|
| Early Rheumatoid Arthritis (RA) | Other | Other: Blood Draw, Other: Disease Activity (DAS-28) Assessment, Other: Skeletal Muscle Mitochondrial Respiratory Capacity, Other: Muscle Biopsy, Other: Body Composition, Other: Cardiopulmonary Exercise Test (CPET), Other: Strength Testing, Other: Questionnaires, Other: Skeletal Muscle Biomechanical Property AssessmentEarly 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 |
| Age-, Sex-, BMI-matched Healthy Controls | Other | Other: Blood Draw, Other: Skeletal Muscle Mitochondrial Respiratory Capacity, Other: Muscle Biopsy, Other: Body Composition, Other: Cardiopulmonary Exercise Test (CPET), Other: Strength Testing, Other: Questionnaires, Other: Skeletal Muscle Biomechanical Property AssessmentHealthy Controls. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Early RA participants will be excluded if they have already started bDMARD therapy.
- The investigators will exclude persons using non-aspirin anticoagulants that would complicate the biopsy. There will be a wash-out period of seven days for anti-platelet agents, and three days for NSAIDs prior to biopsies.
- Uncontrolled thyroid diseases
- Chronic obstructive lung disease
- Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawA study nurse will draw up to 150 mL of blood to measure erythrocyte sedimentation rate (ESR) and measures of immune cell function. ESR is a common hematology test that is a measure of inflammation. | Other | Age-, Sex-, BMI-matched Healthy Controls, Early Rheumatoid Arthritis (RA) |
| Disease Activity (DAS-28) AssessmentParticipants in the RA cohort will receive a 28-joint examination by the study physician to assess RA disease activity and report their overall health assessment. | Other | Early Rheumatoid Arthritis (RA) |
| Skeletal Muscle Mitochondrial Respiratory CapacityAlso: Near-Infrared Spectroscopy (NIRS)Near-Infrared Spectroscopy (NIRS) will be used to measure oxidative capacity of forearm flexor digitorum profundus and medial gastrocnemius muscles using the PortaMon device (Artinis Medical Systems, The Netherlands). NIRS is a low-cost, non-invasive method that estimates muscle oxidative capacity by measuring oxygen consumption (mVO2) recovery kinetics via assessment of intramuscular oxy- and deoxy-hemoglobin concentration following a sequence of brief, rapid arterial cuff occlusions. NIRS measures mitochondrial oxidative function as the mVO2 recovery rate constant k. In the absence of blood flow, changes in muscle oxygenation occur via oxygen consumption alone. In persons without RA, this non-invasive approach is highly correlated with muscle respiratory capacity assessed via muscle biopsies using in situ permiabilized fiber bundles and the Oroboros O2k system. | Other | Age-, Sex-, BMI-matched Healthy Controls, Early Rheumatoid Arthritis (RA) |
| Muscle BiopsyAfter local anesthesia (xylocaine, 2%) is injected, a small incision will be made in the thigh. Four to six small pieces of muscle about the size of a pea will be surgically removed. The incision site will be closed using steri-strips and/or derma-bond, and a light dressing applied. | Other | Age-, Sex-, BMI-matched Healthy Controls, Early Rheumatoid Arthritis (RA) |
| Body CompositionBody composition assessments include circumference measurements and the BOD POD®. Minimal waist circumference measurements will be taken using a tape measure. | Other | Age-, Sex-, BMI-matched Healthy Controls, Early Rheumatoid Arthritis (RA) |
| Cardiopulmonary Exercise Test (CPET)Cardiorespiratory aerobic capacity (VO2 peak), will be assessed using a maximal treadmill test protocol with cardiopulmonary gas exchange. Subjects will be asked to exercise on a treadmill to their perceived maximum ability and effort during which time they will have a mouthpiece in their mouth to determine maximal oxygen use/consumption through breathing. For safety purposes the subject will be monitored by electrocardiogram (ECG) and their blood pressure will be measured at rest and throughout the exercise phase of this test. | Other | Age-, Sex-, BMI-matched Healthy Controls, Early Rheumatoid Arthritis (RA) |
| Strength TestingStrength assessments will include dynamometry-assessed grip and quadriceps strength (Cybex HUMAC NORM, Comp Sports Med, Inc., Stoughton, MA) tests | Other | Age-, Sex-, BMI-matched Healthy Controls, Early Rheumatoid Arthritis (RA) |
| QuestionnairesMeasures include global health, pain, fatigue, physical function, self-efficacy for disease management and sleep. | Other | Age-, Sex-, BMI-matched Healthy Controls, Early Rheumatoid Arthritis (RA) |
| Skeletal Muscle Biomechanical Property AssessmentAlso: MyotonometryPassive skeletal muscle stiffness and elasticity measurements of bilateral biceps brachii, flexor carpi radialis, vastus lateralis, and tibialis anterior using mechanical deformation with myotonometry using the MyotonPro device. | Other | Age-, Sex-, BMI-matched Healthy Controls, Early Rheumatoid Arthritis (RA) |
Primary outcome
Muscle stiffness and elasticity
Time frame: Baseline
Determine whether passive skeletal muscle stiffness (Newtons/meters) and elasticity (logarithmic decrement) are different in RA compared to matched healthy controls.
2 secondary outcomes
Myobundle function
Time frame: Baseline
Janus kinase/signal transducers and activators of transcription 3 pathway (JAK/STAT3) signaling in skeletal muscle
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Derived from this study: PubMed 42015271Hashmi SW, Andonian BJ, Thompson MM, Bennett WC, Sudnick AM, Johnson JL, Ross LM, Collins-Bennett KA, Belski KB, Vinicki M, Pribic T, Lauc G, Krishnan S, Huffman KM. 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. Arthritis Res Ther. 2026 Apr 21;28(1):123. doi: 10.1186/s13075-026-03818-6.
- 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. This study is not recruiting at the moment.
Kim M Huffman, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Draw, Disease Activity (DAS-28) Assessment and Skeletal Muscle Mitochondrial Respiratory Capacity in people with Rheumatoid Arthritis and Healthy Controls, run by Duke University at 1 site in United States.
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 0 inclusion and 12 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: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle stiffness and elasticity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04226131, which also lists 1 linked publication.
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 13 Jul 2023.