FILGOTINIB for Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Aged ≥ 18 years at baseline\n- Rheumatoid arthritis defined by the ACR/EULAR criteria.\n- Treated with a JAK inhibitor, full dose for at least 6 months.\n- The JAK inhibitor is prescribed as monotherapy or combined with a csDMARD with a stable dosage for at least 3 months before inclusion.\n- Being in LDA (CDAI≤10) for at least 6 months.\n- With a CRP level below the laboratory standard within the month before the inclusion visit.\n- Women of childbearing potential (WCBP) must have a negative pregnancy test before starting study"}

Exclusion criteria

• {"criterion_text":"- Concomitant disease needing to be treated by the JAK inhibitor at full-dose (for example inflammatory bowel disease).\n- Fibromyalgia according to the physician’s opinion.\n- Anticipated poor compliance with the strategy.\n- Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.\n- Alcohol and/or drug misuse as determined by the investigator.\n- Pregnancy or breastfeeding.\n- Non-affiliation to the French Social Security System.\n- Patient unwilling to sign the informed consent form\n- Patient under legal protection.\n- Patient with a history of JAK-inhibitor dose reduction/spacing before enrollment in the study with the JAK-inhibitor currently being taken.\n- Evidence of flare-up within the last 6 months prior to the inclusion.\n- Patient who received glucocorticoids > 5mg/day in the 3 months prior the inclusion because of the disease activity of the RA.\n- Patient requiring corticoid joint injections in the 3 months prior to inclusion or with scheduled joint injections, to control disease activity.\n- Patient at risk for complication according to the ANSM (current or past smokers, patients at risk of VTE, cancer or major cardiovascular problems, aged ≥ 65 years) at baseline AND currently taking baricitinib or filgotinib.\n- Patient taking associated bDMARD (including anti-TNF, anti-IL6, anti-CD20, abatacept, anti-IL17, anti-IL12/23, anti-IL23, anti-IL1, anti-BAFF, anti-IL5 pathways).\n- Patient taking immunotherapy for neoplasia.\n- Surgery scheduled in the next 12 months."}

Primary endpoints

• {"endpoint_text":"- the proportion of patients still receiving a JAK-inhibitor and being in CDAI low disease activity at 12 months.","definition_or_measurement_approach":"Measured as the proportion of patients who are still receiving a JAK-inhibitor and meet CDAI low disease activity criteria at 12 months (CDAI ≤ 10)."}

Secondary endpoints

• {"endpoint_text":"- Disease activity over time assessed by CDAI, SDAI and DAS28 scores.","definition_or_measurement_approach":"Disease activity measured longitudinally using CDAI, SDAI and DAS28 composite scores at scheduled visits."}
• {"endpoint_text":"- The delay between the inclusion visit and the first flare diagnosed by a physician. Two definitions of flare will be assessed for this criterion: •\tA flare defined by a CDAI > 10 at any visit. •\tA major flare at any visit, based on the OMERACT definition which is: o\tAn increase in the DAS28-ESR score of more than 1.2 compared to baseline score, o\tOR a DAS28-ESR score increase of more than 0.6 compared to the baseline score AND the current DAS28-ESR score being above 3.2.","definition_or_measurement_approach":"Time-to-first flare from inclusion. Flare definitions: (1) CDAI > 10 at any visit; (2) major flare per OMERACT: DAS28-ESR increase >1.2 vs baseline OR increase >0.6 vs baseline with current DAS28-ESR >3.2."}
• {"endpoint_text":"- The 12-month cumulative glucocorticoid dose including rescue short course of glucocorticoids and glucocorticoid joint injections.","definition_or_measurement_approach":"Sum of systemic glucocorticoid doses over 12 months including rescue short courses and glucocorticoid joint injections (cumulative dose over 12 months)."}
• {"endpoint_text":"- Patient reported outcomes over 12 months including: •\tPain assessed by a visual analogic scale of pain (VAS); •\tFunction assessed by the Health Assessment Questionnaire (HAQ); •\tFlares according to the patient, assessed by the FLARE questionnaire •\tFatigue assessed by a visual analogic scale of fatigue and the FACIT-F questionnaire •\tQuality of life assessed by the EQ-5D-5L and the RAID.","definition_or_measurement_approach":"Patient-reported outcomes collected over 12 months: pain (VAS), function (HAQ), patient-reported flares (FLARE questionnaire), fatigue (VAS and FACIT-F), and quality of life (EQ-5D-5L and RAID)."}
• {"endpoint_text":"- The modified van der Heijde Total Sharp Score variation between baseline visit and 12-month visit.","definition_or_measurement_approach":"Radiographic progression measured as change in modified van der Heijde Total Sharp Score from baseline to 12 months."}
• {"endpoint_text":"- The number of adverse events and severe adverse events at 12 months.","definition_or_measurement_approach":"Count and categorisation of adverse events and serious adverse events occurring within 12 months (including specified categories such as serious infections, major cardiovascular events, thromboembolic events, malignancies)."}
• {"endpoint_text":"- The number and percentage of patients in CDAI low disease activity at 12 months who could reduce the JAK inhibitor dosage in the dose-tapering arm.","definition_or_measurement_approach":"Proportion and count of patients in CDAI low disease activity at 12 months who successfully reduced JAK inhibitor dosage within the tapering arm."}
• {"endpoint_text":"- Incremental cost-utility and cost-effectiveness ratios (ICUR and ICER) from the collective perspective expressed in terms of cost per QALY for the ICUR and cost per patient without major flares for the ICER, at 12 months.","definition_or_measurement_approach":"Health economic analyses at 12 months producing ICUR (cost per QALY) and ICER (cost per patient without major flares) from the collective perspective."}
• {"endpoint_text":"- Occupation, level of income and level of education will be recorded to test the impact of socioeconomic characteristics on care costs and efficiency at 12 months.","definition_or_measurement_approach":"Collection of socioeconomic variables (occupation, income level, education) to analyse their association with costs of care and efficiency outcomes at 12 months."}

France

Earliest CTIS Part Ii Submission Date

21-05-2024

Latest Decision Or Authorization Date

27-11-2024

Processing Time Days

190

Number Of Sites

24

Number Of Participants

308

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France