Rituximab for Rheumatoid Arthritis

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Diagnosis of rheumatoid arthritis (RA) according to EULAR/ACR 2010 classification criteria\n- DAS28 ≤ 5.1\n- Current maintenance treatment with Rituximab regardless of dose and/or duration of Rituximab treatment and with at least first cycle of Rituximab ended (2 initial infusions)\n- Last Rituximab infusion between 6 and 18 months prior to day 0\n- Corticosteroids ≤10 mg/day within 4 weeks prior to day 0\n- Affiliation to a social insurance system or beneficiary\n- Written informed consent to participate in the study, dated and signed before starting the trial\n- Effective method of birth control during the study"}

Exclusion criteria

• {"criterion_text":"- Rheumatic autoimmune disease other than RA (except associated Sjogren’s disease, which is allowed)\n- Patients over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision\n- Subject in exclusion period (determined by a previous or ongoing study)\n- Patients unable to give informed consent (e.g., patients in a situation of medical emergency, patients who have difficulty comprehending the essential details of the trial...)\n- Patients who have difficulty reading or understanding French, or who have an inability to understand the delivered information\n- Concurrent treatment with any other targeted therapy than Rituximab\n- Any contraindication to Rituximab or to NaCl 0.9%\n- Significant uncontrolled associated disease or comorbidity\n- Known active infection or history of serious recurrent or chronic infection\n- Laboratory findings: active or untreated latent tuberculosis, hepatitis B positive, hepatitis C positive, haemoglobin <8 g/dL, neutropenia < 1.5G/L or IgG <5 g/L\n- Pregnancy (women of childbearing potential : positive urinary pregnancy test at the inclusion visit), breastfeeding, or planned pregnancy during the study (on subject declaration)\n- Drug addiction, alcohol addiction\n- Patients who cannot be followed for the 12 month-duration"}

Primary endpoints

• {"endpoint_text":"- Mean reduction of rheumatoid arthritis activity score (DAS28-CRP) between day 0 and 12 months to show non-inferiority of the lower dose.","definition_or_measurement_approach":"Mean DAS28-CRP measured between day 0 and 12 months; non-inferiority comparison of 200 mg versus 1 g rituximab using mean DAS28-CRP change over 12 months."}

Secondary endpoints

• {"endpoint_text":"- DAS28-CRP at day 0, 6 months and 12 months","definition_or_measurement_approach":"DAS28-CRP measured at day 0, 6 months and 12 months"}
• {"endpoint_text":"- DAS28 categories : Remission: DAS28 < 2.6 ; Low Disease Activity: 2.6 ≤ DAS28 ≤ 3.2 ; Moderate Activity: 3.2 < DAS28 ≤ 5.1; High Disease Activity: DAS28 > 5.1 ; Boolean Remission Criteria defined as tender joint count (TJC) ≤ 1, swollen joint count (SJC) ≤ 1, CRP (mg/dL) ≤ 1, Patient global assessment (on a 0–10 scale) ≤ 1 at day 0, 6 months and 12 months","definition_or_measurement_approach":"Categorical DAS28 outcomes and Boolean remission criteria assessed at day 0, 6 months and 12 months"}
• {"endpoint_text":"- Number of Rituximab infusions, number of patients switching or initiating a cDMARD or switching from Rituximab to another bDMARD, number of patients using oral corticosteroids at a dose greater than 10 mg/day throughout study period","definition_or_measurement_approach":"Counts over the study period of rituximab infusions, treatment switches/initiations, and patients on >10 mg/day oral corticosteroids"}
• {"endpoint_text":"- Number of flares throughout study period, FLARE questionnaire at 6 and 12 months","definition_or_measurement_approach":"Number of disease flares recorded during study; FLARE questionnaire administered at 6 and 12 months"}
• {"endpoint_text":"- RAPID-3 score and RAID at day 0, 6 months and 12 months","definition_or_measurement_approach":"Patient-reported RAPID-3 and RAID scores at day 0, 6 and 12 months"}
• {"endpoint_text":"- EQ5D-5L and SF-36 at day 0, 6 months and 12 months","definition_or_measurement_approach":"Health-related quality of life assessed by EQ5D-5L and SF-36 at specified timepoints"}
• {"endpoint_text":"- B, T and NK cell phenotyping at day 0, 6 months and 12 months","definition_or_measurement_approach":"Immune cell subpopulation phenotyping at day 0, 6 and 12 months"}
• {"endpoint_text":"- IgG, IgA and IgM at day 0, 6 months and 12 months","definition_or_measurement_approach":"Serum immunoglobulin levels (IgG, IgA, IgM) measured at day 0, 6 and 12 months"}
• {"endpoint_text":"- Vaccinal serologies at day 0, 6 months and 12 months (Diphteria, pneumococcus, tetanus and Haemophilus influenzae type B)","definition_or_measurement_approach":"Serology results for listed vaccines at day 0, 6 and 12 months"}
• {"endpoint_text":"- HACA at day 0 and 12 months","definition_or_measurement_approach":"Human antichimeric antibody (HACA) levels measured at day 0 and 12 months"}
• {"endpoint_text":"- Evolution of Torque Teno Virus (TTV) viral load in the serum of patients between day 0 and 12 months","definition_or_measurement_approach":"TTV viral load measured in serum at day 0 and 12 months to monitor humoral immunosuppression"}
• {"endpoint_text":"- Number of infections and serious infections","definition_or_measurement_approach":"Count of infections and serious infections during the study period"}
• {"endpoint_text":"- Number of adverse events and serious adverse events","definition_or_measurement_approach":"Count of adverse events and serious adverse events recorded during the study period"}

France

Earliest CTIS Part Ii Submission Date

27-03-2025

Latest Decision Or Authorization Date

11-04-2025

Processing Time Days

15

Number Of Sites

24

Number Of Participants

249

Primary sponsor

Full Name

Les Hopitaux Universitaires De Strasbourg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France