[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05038553":3,"trial-entities:NCT05038553":94,"trial-summary:NCT05038553":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":15,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":31,"secondary_outcomes":36,"sex":37,"minimum_age":38,"maximum_age":15,"healthy_volunteers":39,"eligibility_criteria":40,"std_ages":44,"locations":47,"central_contacts":87,"overall_officials":88,"references":92,"see_also_links":93},"NCT05038553","STU00211593","Chronic Pain in Rheumatoid Arthritis","CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition","ACTIVE_NOT_RECRUITING","2027-02-28","2026-05","2026-05-28","2021-10-12","Northwestern University","OTHER",null,"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.",[18,19],"Arthritis, Rheumatoid","Pain",[],"OBSERVATIONAL",[],{"count":24,"type":25},125,"ESTIMATED",[27],{"type":14,"name":28,"description":28,"armGroupLabels":29},"No intervention",[30],"Patients with early rheumatoid arthritis",[32],{"measure":33,"description":34,"timeFrame":35},"Fibromyalgia Survey Criteria","Minimum value 0, maximum value 31; higher scores indicate worse outcomes","12 months",[],"ALL","18 Years",false,{"inclusion":41,"exclusion":42,"raw_text":43},[],[],"Inclusion Criteria for QST:\n\n1. Age ≥18 years\n2. Meet either the 1987 or 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) criteria for RA\n3. Persistent joint symptoms ≤ 2 years\n4. Active inflammatory disease\n5. If taking opioids on an as needed (prn) basis, must be able to hold opioid for 12 hours before study procedures\n6. If taking NSAIDs, must be able to hold NSAIDS for 24 hours before study procedures\n7. If taking a central-acting pain medication, must be on a stable dose and able to stay on a stable dose throughout study\n\nExclusion Criteria for QST:\n\n1. Routine, scheduled opioid use\n2. Routine, scheduled prednisone dose \\>10 mg or its equivalent\n3. Peripheral neuropathy\n4. Peripheral vascular disease\n5. Raynaud's phenomenon requiring treatment, manifested by claudication or ischemic rest pain\n6. Uncontrolled blood pressure\n\nAdditional Inclusion Criteria for neuroimaging:\n\n1. Age ≤ 80 years old\n2. Right-handed or ambidextrous\n3. Ability to lie on their back for the duration of the MRI scans\n\nAdditional Exclusion Criteria for neuroimaging:\n\n1. Severe claustrophobia precluding MRI\n2. Unable to fit comfortably in the MRI scanner (usually only occurs if body mass index \\>40 kg\u002Fm2)\n3. Pregnant\n4. Contraindications to MRI",[45,46],"ADULT","OLDER_ADULT",[48,57,64,72,80],{"facility":49,"city":50,"state":51,"zip":52,"country":53,"geoPoint":54},"University of Colorado","Denver","Colorado","80045","United States",{"lat":55,"lon":56},39.73915,-104.9847,{"facility":13,"city":58,"state":59,"zip":60,"country":53,"geoPoint":61},"Chicago","Illinois","60611",{"lat":62,"lon":63},41.85003,-87.65005,{"facility":65,"city":66,"state":67,"zip":68,"country":53,"geoPoint":69},"Johns Hopkins University","Baltimore","Maryland","21224",{"lat":70,"lon":71},39.29038,-76.61219,{"facility":73,"city":74,"state":75,"zip":76,"country":53,"geoPoint":77},"University of Michigan","Ann Arbor","Michigan","48019",{"lat":78,"lon":79},42.27756,-83.74088,{"facility":81,"city":82,"state":82,"zip":83,"country":53,"geoPoint":84},"Hospital for Special Surgery","New York","10021",{"lat":85,"lon":86},40.71427,-74.00597,[],[89],{"name":90,"affiliation":13,"role":91},"Yvonne C Lee, MD, MMSc","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Rheumatoid Arthritis",[],{"nct_id":4,"found":39,"summary":15,"prompt_version":15}]