NCT05038553

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 12, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

4.6 years

First QC Date

August 30, 2021

Last Update Submit

April 24, 2025

Conditions

Arthritis, RheumatoidPain

Outcome Measures

Primary Outcomes (1)

  • Fibromyalgia Survey Criteria

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

    12 months

Study Arms (1)

Patients with early rheumatoid arthritis

Other: No intervention

Interventions

No interventionOTHER

No intervention

Patients with early rheumatoid arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with early RA recruited from academic medical centers

You may qualify if:

  • Age ≥18 years
  • Meet either the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA
  • Persistent joint symptoms ≤ 2 years
  • Active inflammatory disease
  • If taking opioids on an as needed (prn) basis, must be able to hold opioid for 12 hours before study procedures
  • If taking NSAIDs, must be able to hold NSAIDS for 24 hours before study procedures
  • If taking a central-acting pain medication, must be on a stable dose and able to stay on a stable dose throughout study

You may not qualify if:

  • Routine, scheduled opioid use
  • Routine, scheduled prednisone dose \>10 mg or its equivalent
  • Peripheral neuropathy
  • Peripheral vascular disease
  • Raynaud's phenomenon requiring treatment, manifested by claudication or ischemic rest pain
  • Uncontrolled blood pressure
  • Age ≤ 80 years old
  • Right-handed or ambidextrous
  • Ability to lie on their back for the duration of the MRI scans
  • Severe claustrophobia precluding MRI
  • Unable to fit comfortably in the MRI scanner (usually only occurs if body mass index \>40 kg/m2)
  • Pregnant
  • Contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Colorado

Denver, Colorado, 80045, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21224, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48019, United States

RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yvonne C Lee, MD, MMSc

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Aren, MPH

CONTACT

312-503-1824kathleen.aren@northwestern.edu

Mary Carns, MS

CONTACT

312-503-1137m-carns@northwestern.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Preventive Medicine

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 9, 2021

Study Start

October 12, 2021

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(5)