Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT05822856
Eligibility Criteria:
Inclusion Criteria:
For all :
\- Age ≥ 18 years old
For A1 Group (3 groups of RA patients of 25 patients each):
\- Subject with Rheumatoid Arthritis (RA) meeting the American College of Rheumatology / European League Against Rheumatism ACR/EULAR 2010 criteria, without disease-modifying treatment or with conventional treatment initiated for at least 3 months (at stable dosage for more than 6 weeks)
For A1-1 group : active RA
* DAS28\>3.2 with increased CRP (\> laboratory standard),
* VAS (Visual Analogic Scale)\>5/10 with no other explanation than inflammatory rheumatism
For A1-2 group : RA without inflammation with persistent chronic pain (\>3 months) despite control of inflammation and no other identified cause:
* no swollen joint,
* CRP normal (\< laboratory standard),
* VAS\>5/10
For A1-3 groupe : RA in remission without pain:
* DAS28 ≤2.6,
* no swollen joint,
* CRP normal (\< laboratory standard),
* VAS≤2/10
For A2 Group (1 group of 25 Fibromyalgia patients):
* Subjects with Fibromyalgia meeting 2016 diagnostic criteria
* VAS\>5/10
* FIRST (FIbromyalgia Rapid Screening Tool) ≥5
For A3 Group (1 group of 25 healthy subjects ):
* healthy and pain-free controls subjects with no progressive disease,
* VAS≤2/10,
* FIRST =0
Exclusion Criteria:
* biological therapy for RA: within the previous year for rituximab, within \< 4 intervals between anti-TNF, anti-IL6R, or CTLA4-Ig injections and within the previous 15 days for JAKi (JAK inhibitor)
* Corticosteroids \> 10 mg/d per os at inclusion
* Corticosteroids \> 20 mg/d per os or bolus within 15 days prior to inclusion
* Non-steroidal anti-inflammatory drugs (NSAIDs) and pain medication in the previous week
* Current oral anti-diabetic or proton pump inhibitor (PPI) therapy
* Antibiotic therapy in the previous 3 months
* Infection, cancer in the last 5 years prior to inclusion
* History of other systemic inflammatory/autoimmune diseases
* Not affiliated to a social security
* Patient unwilling or unable to give consent: patient under guardianship or conservatorship,
* Mentally impaired, dementia, language barrier
* Patient under court protection
* Pregnant or breastfeeding woman
* Refusal of written consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05822856
Study Brief:
Protocol Section:
NCT05822856