Integrative AI-Based Multiomic and Neurophysiological Profiling of Chronic Pain in Rheumatoid Arthritis
RecruitingNCT07769619
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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-reported outcome measures, neurophysiological evaluation, and multiomic profiling, analyzed using artificial intelligence (AI)-based methods. Two groups of adult patients with RA are enrolled: a study group of patients with active disease qualifying for biological therapy under the Polish national drug program B.33, and a control group of patients in sustained clinical remission (at least 1.5 years) under biological therapy, without clinically significant chronic pain. All participants undergo clinical assessment, standardized questionnaires, peripheral blood collection at the baseline (Visit 1) and follow-up (Visit 2) visits. Electroencephalography (EEG) is offered as an optional procedure, at the discretion of the investigator. Biological samples are analyzed using advanced multiomic technologies, including whole genome sequencing (genomics), mRNA expression profiling (transcriptomics), and measurement of circulating proteins (secretomics). All clinical, biological, and neurophysiological data are then integrated using AI methods, including dimensionality reduction, clustering, and…
Study details
- Official title
- Integrative AI-Based Multiomic and Neurophysiological Profiling of Chronic Pain in Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis (RA
- Chronic Pain
- Sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland
- Collaborators
- Lukasiewicz - PORT Polish Center for Technology Development; Wrocław University of Science and Technology; Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
- Start date
- 2026-06-01
- Primary completion
- 2028-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Poland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07769619