CPIRA-2: Chronic Pain in Rheumatoid Arthritis

• Sponsor: Northwestern University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05038553
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), University of Michigan (Other), Hospital for Special Surgery, New York (Other), University of Colorado, Denver (Other), Johns Hopkins University (Other)
• Enrollment: 125
• Locations: 5
• Anticipated Duration (Months): 54
• Patients Per Site: 25
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid; Pain	Other: No intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 125 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition
• Actual Study Start Date: Oct 12, 2021
• Anticipated Primary Completion Date: Oct 12, 2025
• Anticipated Study Completion Date: Apr 12, 2026

Arms and Interventions

Arm	Intervention/Treatment
Patients with early rheumatoid arthritis	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. Fibromyalgia Survey Criteria [12 months]

   Minimum value 0, maximum value 31; higher scores indicate worse outcomes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 ≤ 1 year

4. Active inflammatory disease

5. If taking opioids on an as needed (prn) basis, must be able to hold opioid for 48 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 <75 years old

2. Right-handed

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. Body mass index >40 kg/m2

3. Pregnant

4. Contraindications to MRI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado	Denver	Colorado	United States	80045
2	Northwestern University	Chicago	Illinois	United States	60611
3	Johns Hopkins University	Baltimore	Maryland	United States	21224
4	University of Michigan	Ann Arbor	Michigan	United States	48019
5	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Yvonne C Lee, MD, MMSc, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yvonne Lee, Associate Professor of Medicine and Preventive Medicine, Northwestern University
• ClinicalTrials.gov Identifier: NCT05038553
• Other Study ID Numbers: STU00211593; R01AR064850
• First Posted: Sep 9, 2021
• Last Update Posted: Nov 26, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Chronic Pain

Study Results

No Results Posted as of Nov 26, 2021