Status:
TERMINATED
JAKPOT (JAK Inhibitors and Predictors of Outcome in RheumaToid Arthritis)
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Centre Hospitalier Universitaire de Nīmes
University Hospital, Clermont-Ferrand
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rheumatoid arthritis (RA) is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient's qual...
Detailed Description
Ultrasound (US) is an imaging technique increasingly used in rheumatologic practice. US is a noninvasive, bedside, objective and sensitive tool for visualizing synovial inflammatory joint changes in R...
Eligibility Criteria
Inclusion
- Patient ≥18 years
- 2010 (American College of Rheumatology) ACR-EULAR classification criteria for RA for ≥3 months
- Inadequate response to MTX (or other csDMARD) for ≥3 months, at stable dosage for ≥1 month
- Active disease defined by DAS28\>3,2 AND presence of ≥2 US synovitis with Power-Doppler≥2,
- Starting a treatment with JAKi (baricitinib or tofacitinib),
- Patients previously treated with biologic (stopped for inadequate response or safety) could be included. Biologics will be stopped before entering in the study: Abatacept and all TNF (tumor necrosis factor) inhibitors: no use within 4 weeks before baseline visit; Rituximab: no use within 6 months before baseline visit.
- Informed signed consent
Exclusion
- Patient not treated before by MTX (or other csDMARD). Patients with a contraindication or in whom MTX was stopped due to safety issue could be included. Patients treated by MTX will have MTX during the follow-up, others will be treated by JAKi monotherapy,
- Patients with a contraindication to baricitinib or tofacitinib (current infection, recent attenuated vaccine injection, cancer \<5 years…) or treated previously with baricitinib or tofacitinib,
- Patients treated by glucocorticoids ≥10 mg/day and unstable dosage for \<1 month or with ≥1 glucocorticoids injection \<1 month.
- RA with Steinbrocker class IV damage status
- General exclusion criteria (pregnancy, breast feeding…)
- Refusal to participate in the study
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04084223
Start Date
October 10 2019
End Date
September 24 2024
Last Update
January 10 2025
Active Locations (1)
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1
Rheumatology Department, Lapeyronie Hospital
Montpellier, France, 34295