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

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat reumatoid artritiszes felnőtteket keres. Az egyik csoport aktív betegségű, és biológiai terápia megkezdése előtt áll. A másik csoport biológiai terápia mellett remisszióban van, és nincs krónikus fájdalma.

Életkor

18 éves vagy idősebb

Nem

Minden nem

A betegség stádiuma

Két csoport: aktív reumatoid artritisz, amely biológiai terápiát igényel a lengyel B.33 gyógyszerprogram szerint, vagy legalább 1.5 éve tartó remisszióban lévő reumatoid artritisz biológiai terápia mellett, jelenleg krónikus fájdalom nélkül.

Korábbi kezelés

A remissziós csoportnak biológiai terápiát kell kapnia, jól tolerálva, legalább 1.5 éve tartó remisszióval. Az aktív csoport biológiai terápia megkezdése előtt áll.

A részvétel fő kizáró okai

• A biológiai terápia ellenjavallata (aktív csoport)
• Nem tud tájékozott beleegyezést adni
• Bármely olyan állapot, amely a vizsgáló szerint zavarhatja a részvételt vagy az adatok értelmezését

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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 supervised machine learning, to identify distinct pain-related patient subtypes (endotypes). The primary objective of the study is to identify and characterize clinical, neurophysiological, and multiomic signatures associated with chronic pain in RA. Expected outcomes include identification of biomarkers predictive of chronic pain persistence despite effective anti-inflammatory treatment, improved differentiation between inflammation-driven pain and pain mediated by central nervous system changes, and support for the development of more personalized, mechanism-based treatment strategies in rheumatology. The study is non-interventional: no experimental therapeutic interventions are administered, and all participants continue to receive standard clinical care. All biological analyses are performed ex vivo.

A vizsgálat 2 csoportja

• Group 1 - Active RA With Chronic Pain (Study Group)

  Group 1 - Active RA With Chronic Pain (Study Group) Description: Adult patients with confirmed rheumatoid arthritis in the active phase of disease, qualified for initiation of biological therapy under the Polish national drug program B.33 (Treatment of rheumatoid arthritis and juvenile idiopathic arthritis with aggressive course; ICD-10: M05, M06, M08). Participants undergo clinical assessment, biological sample collection (peripheral blood approximately 30 mL), standardized questionnaire evaluation, and, optionally (at the discretion of the investigator), EEG assessment. Intervention(s): No therapeutic intervention. Study procedures: blood collection, PROM assessment, optional EEG (at the discretion of the investigator), multiomic profiling (ex vivo).

• Group 2 - RA in Sustained Remission Without Chronic Pain (Control Group)

  Description: Adult patients with confirmed rheumatoid arthritis in sustained clinical remission for at least 1.5 years under biological therapy, with good treatment tolerance and not reporting current chronic pain in clinical interview. Participants undergo the same assessment procedures as the study group. Intervention(s): No therapeutic intervention. Same study procedures as Group 1.