Chronic Pain in Rheumatoid Arthritis

Pain Clinical Trial

— CPIRA-2  

Official title:

CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05038553
• Other study ID #: STU00211593
• Secondary ID: R01AR064850
• Status: Recruiting
• Start date: October 12, 2021
• Est. completion date: April 12, 2026

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: Kathleen Aren, MPH
• Phone: 312-503-1824
• Email: kathleen.aren[@]northwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: April 12, 2026
• Est. primary completion date: February 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Chronic Pain
• Pain

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	University of Colorado	Denver	Colorado
United States	Hospital for Special Surgery	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
Northwestern University	Hospital for Special Surgery, New York, Johns Hopkins University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Colorado, Denver, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Survey Criteria	Minimum value 0, maximum value 31; higher scores indicate worse outcomes	12 months