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Active, not recruitingNCT05038553CPIRA-2Updated May 28, 2026

Chronic Pain in Rheumatoid Arthritis

An observational study in Arthritis, Rheumatoid and Pain, sponsored by Northwestern University. Active, not recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Northwestern University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
125
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Arthritis, Rheumatoid
  • Pain
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's planned enrollment of 125 is below the median of 176 across 824 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with early RA recruited from academic medical centers

Inclusion criteria

  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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
125 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with early rheumatoid arthritis

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Fibromyalgia Survey Criteria

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

    Time frame: 12 months

07

Study locations

5 sites
  • University of Colorado
    Denver, Colorado 80045, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Johns Hopkins University
    Baltimore, Maryland 21224, United States
  • University of Michigan
    Ann Arbor, Michigan 48019, United States
  • Hospital for Special Surgery
    New York, New York 10021, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05038553
Lead sponsor
Northwestern University
Collaborators
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
Responsible party
Yvonne Lee (Associate Professor of Medicine and Preventive Medicine, Northwestern University) — Principal investigator
First posted
Sep 9, 2021
Start date
Oct 12, 2021
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
May 28, 2026

Study contacts

Yvonne C Lee, MD, MMSc
principal investigator · Northwestern University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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