JAKPOT (JAK Inhibitors and Predictors of Outcome in RheumaToid Arthritis)

Trial details

Who runs it

University Hospital, Montpellier

Trial code

NCT04084223

Record updated

2025. január 10.

Original description

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 quality of life and function.Read full original descriptionShow less

Added Value of Early Collected Ultrasound As Compared to Clinical Evaluation to Predict Definite Clinical Outcome and Therapeutic Response in Rheumatoid Arthritis Patients Treated by JAK Inhibitors

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 quality of life and function.

Sustained remission or low disease activity is the target to achieve in RA management. Ultrasound (US) is an imaging technique potentially helpful at several steps of the disease. A semi-quantitative (0-3) score of synovitis combining B-mode and Power Doppler abnormalities has been developed (GLOESS), and its responsiveness has been demonstrated. Patients Reported Outcomes (PROs) are important parameters in patient perceived health and are increasingly used in clinical practice. Prediction of therapeutic response to biological and targeted synthetic DMARDs remains a challenge for clinician, due to the potential adverse events and the cost of these drugs. To date, only few clinical and biological tools usable in clinical practice have a prognostic value. US or PRO could have added value for this purpose.

Objectives :

* To determine the predictive added value of the variation of an US score to the variation of the DAS28-CRP (C-Reactive Protein) at 1 month on clinical outcome (low disease activity i.e. DAS28-CRP≤3.2) at 6 months, or on therapeutic response at 3 months (EULAR good or moderate response (DAS)), in RA patients starting a treatment with JAK (Janus Kinase) inhibitors (JAKi). * To determine the predictive added value of the variation several PROs to the variation of the DAS28-CRP at 1 month on clinical outcome (low disease activity i.e. DAS28-CRP≤3.2) at 6 months, or on therapeutic response at 3 months (EULAR good or moderate response (DAS)), in RA patients starting a treatment with JAKi.

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: Patients with a contraindication to baricitinib or tofacitinib (current infection, recent attenuated vaccine injection, cancer <5 years…) or treated previously with baricitinib or tofacitinib,; 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 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.

ClinicalTrials.gov NCT04084223