Chronic Pain in Rheumatoid Arthritis (CPIRA-2)

Northwestern University

Status: Enrolling

Conditions: Pain; Arthritis, Rheumatoid

Treatments: Other: No intervention

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05038553

STU00211593

R01AR064850 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

125 participants in 1 patient group

Patients with early rheumatoid arthritis

Treatment:

Other: No intervention