Arthritis, RheumatoidCPIRA-2NCT05038553
Chronic Pain in Rheumatoid Arthritis
An observational study of Arthritis, Rheumatoid and Pain, run by Northwestern University at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Pain
- How many people
- 125 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Oct 2021to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with early RA recruited from academic medical centers
Who may be able to join
- 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
Who cannot join
- 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
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- Additional Inclusion Criteria for neuroimaging:
- Age ≤ 80 years old
- Right-handed or ambidextrous
- Ability to lie on their back for the duration of the MRI scans
- Additional Exclusion Criteria for neuroimaging:
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48019
Johns Hopkins University
Baltimore, Maryland, 21224
Northwestern University
Chicago, Illinois, 60611
University of Colorado
Denver, Colorado, 80045
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition
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.
- Conditions
- Arthritis, Rheumatoid, Pain
- Being tested
- No intervention
- Medical subject headings
- Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with early rheumatoid arthritis | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Survey Criteria
Minimum value 0, maximum value 31; higher scores indicate worse outcomes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start12 Oct 2021
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Yvonne Lee, Northwestern University
- Investigators
- Yvonne C Lee, MD, MMSc, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038553
- Sponsor's protocol ID
- STU00211593
- Other IDs
- R01AR064850
- Acronym
- CPIRA-2
- Status last verified
- May 2026
- First submitted
- 30 Aug 2021
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition
- ClinicalTrials.gov ID
- NCT05038553
- Acronym / sponsor ID
- CPIRA-2 / STU00211593
- Conditions
- Arthritis, Rheumatoid, Pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- 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
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with early rheumatoid arthritis | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early RA recruited from academic medical centers
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Patients with early rheumatoid arthritis |
Primary outcome
Fibromyalgia Survey Criteria
Time frame: 12 months
Minimum value 0, maximum value 31; higher scores indicate worse outcomes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne C Lee, MD, MMSc principal investigator
Northwestern University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Pain, run by Northwestern University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Survey Criteria (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.