Chronic Pain in Rheumatoid Arthritis

NCT ID: NCT05038553

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-12

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis, Rheumatoid Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with early rheumatoid arthritis

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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


1. Age ≤ 80 years old
2. Right-handed or ambidextrous
3. Ability to lie on their back for the duration of the MRI scans

Exclusion Criteria

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


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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Yvonne Lee

Associate Professor of Medicine and Preventive Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yvonne C Lee, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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University of Colorado

Denver, Colorado, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Hospital for Special Surgery

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen Aren, MPH

Role: CONTACT

312-503-1824

Mary Carns, MS

Role: CONTACT

312-503-1137

Facility Contacts

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Marie Feser

Role: primary

303-724-7510

Kathleen Aren, MPH

Role: primary

312-503-1824

Marilyn Towns

Role: primary

410-550-0579

Courtney Cole

Role: primary

734-998-7021

Caroline E Reidy, MPH

Role: primary

646-714-6307

Other Identifiers

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R01AR064850

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00211593

Identifier Type: -

Identifier Source: org_study_id

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