Identifying new biomarkers in rheumatoid arthritis patients receiving anti-TNFalpha therapy
Study of the Functional Status Neutrophils in Rheumatoid Arthritis Patients to Identify New Biomarkers of Response to Anti-TNFalpha Therapy
This study is testing if certain immune cells in the blood can help predict how well rheumatoid arthritis patients will respond to a specific treatment called anti-TNFalpha therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | adalimumab, Rituximab |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05802719 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the functional status of neutrophils and other myeloid cells in patients with rheumatoid arthritis (RA) to identify biomarkers that predict responses to anti-TNFalpha therapy. Blood samples will be collected from RA patients before and after treatment to assess changes in these immune cells. By understanding how these cells function and their role in RA, the study seeks to improve treatment strategies and outcomes for patients. The study will follow participants for six months to evaluate the effectiveness of the therapy based on the identified biomarkers.
Who should consider this trial
Good fit: Ideal candidates include adults with established rheumatoid arthritis who are starting anti-TNFalpha treatment and have active disease.
Not a fit: Patients currently receiving certain immunosuppressive treatments or those with contraindications to TNF inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for rheumatoid arthritis patients.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for treatment response in rheumatoid arthritis, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Established RA patients fulfilling 2010 ACR/EULAR (American College of Rheumatology / European League Against Rheumatism) definition Active disease (DAS28 score (Disease Activity Score) \> 3.2) * Indication to start an anti-TNFalpha treatment : adalimumab or etanercept * 18 years old or older Exclusion Criteria: * Current treatment or within 12 months prior to inclusion with Rituximab * Current treatment or within 1 month prior to inclusion with corticosteroids \>10 mg/day (oral or intravenous) * Contra-indication to TNF inhibitors (active infections, cancer in the last 5 years, active tuberculosis, hepatitis B or C or HIV positive except for hepatitis B vaccination) * Severe intercurrent inflammatory disease * Patient unable to give consent : under guardianship, curators or safeguard of justice; * Pregnant, parturient or nursing woman. * Participation in an interventional clinical trial * Patient refusing to give oral informed consent
Where this trial is running
Montpellier
- Centre Hospitalier Universitaire de Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Christian JORGENSEN, MD PhD
- Email: c-jorgensen@chu-montpellier.fr
- Phone: 04 67 33 77 98
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.