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Integrative AI-Based Multiomic and Neurophysiological Profiling of Chronic Pain in Rheumatoid Arthritis

Recruitingn/aAges 18 Years - anyAll4th Military Clinical Hospital with Polyclinic, P…
NCT07769619 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rheumatoid arthritis (RA) is a chronic, systemic autoimmune disease in which pain remains the most prominent and burdensome symptom from the patient's perspective. Although the introduction of biological and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs and tsDMARDs) has significantly improved the control of inflammatory activity, an estimated 20-30% of patients continues to experience persistent moderate-to-severe pain despite achieving clinical remission. This discordance between objective inflammatory markers and subjective pain perception reflects an important unmet clinical need and suggests that chronic pain in RA may become partially or fully independent of peripheral inflammation, driven instead by central sensitization and nociplastic mechanisms. The RA-PAIN-AI study is a prospective, observational, case-control study integrating clinical assessment, patient-

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📋 Eligibility rules (as published)
Inclusion Criteria - Study Group (Active RA) * Age ≥18 years. * Confirmed diagnosis of rheumatoid arthritis according to applicable classification criteria. * Active phase of the disease requiring initiation of biological therapy. * Qualification for treatment under the national drug program B.33: "Treatment of rheumatoid arthritis and juvenile idiopathic arthritis with aggressive course (ICD-10: M05, M06, M08)". * Ability to provide written informed consent. * Willingness to participate in clinical assessments, EEG, biological sample collection, and questionnaire-based evaluation. Exclusion Criteria - Study Group * Contraindications to biological therapy as defined by the Polish Society of Rheumatology recommendations and the National Health Fund (NFZ) requirements under the B.33 drug program. * Inability to provide informed consent. * Any condition that, in the opinion of the investigator, may interfere with study participation or data interpretation. Inclusion Criteria - Control Group (RA in Remission) * Age ≥18 years * Confirmed diagnosis of rheumatoid arthritis. * Ongoing biological therapy with sustained remission for at least 1.5 years and good tolerance of the treatment. * No current chronic pain reported in the clinical interview. * Ability to provide written informed consent. * Willingness to participate in study procedures, including biological sampling, EEG and questionnaire assessments.
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What it tests

  • Not listed
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Where

1 site
4th Military Clinical Hospital with Polyclinic (4WSzKzP SPZOZ)
Wroclaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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