Chronic Pain in Rheumatoid Arthritis

Study Purpose

The objective is to identify modifiable clinical factors and neurobiological pathways that lead to the development of chronic pain in patients with early rheumatoid arthritis. Participants will undergo quantitative sensory testing, a type of testing that involves assessing response to well-defined, quantifiable painful stimuli, at 0, 3, and 12 months. A subset of participants will also undergo magnetic resonance imaging at 0 and 12 months to assess neuroimaging markers that have previously been shown to be involved in chronic pain.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria for QST: 1. Age ≥18 years. 2. Meet either the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA. 3. Persistent joint symptoms ≤ 2 years. 4. Active inflammatory disease. 5. If taking opioids on an as needed (prn) basis, must be able to hold opioid for 12 hours before study procedures. 6. If taking NSAIDs, must be able to hold NSAIDS for 24 hours before study procedures. 7. If taking a central-acting pain medication, must be on a stable dose and able to stay on a stable dose throughout study. Exclusion Criteria for QST: 1. Routine, scheduled opioid use. 2. Routine, scheduled prednisone dose >10 mg or its equivalent. 3. Peripheral neuropathy. 4. Peripheral vascular disease. 5. Raynaud's phenomenon requiring treatment, manifested by claudication or ischemic rest pain. 6. Uncontrolled blood pressure. Additional Inclusion Criteria for neuroimaging: 1. Age ≤ 80 years old. 2. Right-handed or ambidextrous. 3. Ability to lie on their back for the duration of the MRI scans. Additional Exclusion Criteria for neuroimaging: 1. Severe claustrophobia precluding MRI. 2. Unable to fit comfortably in the MRI scanner (usually only occurs if body mass index >40 kg/m2) 3. Pregnant. 4. Contraindications to MRI

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05038553
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northwestern University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yvonne C Lee, MD, MMSc
Principal Investigator Affiliation Northwestern University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Rheumatoid, Pain
Arms & Interventions

Arms

: Patients with early rheumatoid arthritis

Interventions

Other: - No intervention

No intervention

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Colorado, Denver, Colorado

Status

Recruiting

Address

University of Colorado

Denver, Colorado, 80045

Site Contact

Marie Feser

[email protected]

303-724-7510

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Kathleen Aren, MPH

[email protected]

312-503-1824

Johns Hopkins University, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University

Baltimore, Maryland, 21224

Site Contact

Marilyn Towns

[email protected]

410-550-0579

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48019

Site Contact

Courtney Cole

[email protected]

734-998-7021

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Caroline E Reidy, MPH

[email protected]

646-714-6307