Integrative AI profiling of chronic RA pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, case-control study that combines clinical assessments, patient-reported outcomes, neurophysiological testing, and multiomic profiling to explore chronic pain in rheumatoid arthritis beyond inflammation. Participants include adults with active RA requiring biological therapy and matched controls, analyzed with artificial intelligence approaches. The goal is to identify biomarkers and pain endotypes related to central sensitization and nociplastic mechanisms that persist despite remission of inflammatory activity. Data will be collected from clinical visits, questionnaires, EEG, and biological samples to map relationships between molecular profiles, neurophysiology, and patient-reported pain experiences.

Why it matters

Who can join: the full rules

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.

Where it's running

• 4th Military Clinical Hospital with Polyclinic (4WSzKzP SPZOZ)
  Wroclaw, Poland Recruiting

Study contacts

• Principal investigator: Mariusz Kiszka, Płk lek. — 4th Military Clinical Hospital with Polyclinic (4WSzKzP SPZOZ)
• Study coordinator: Wojciech Tanski, gen. bryg. dr hab. n. med.
• Email: cwbk@4wsk.pl
• Phone: 0048261 660 321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.