86
Participants
Start Date
April 30, 2025
Primary Completion Date
April 30, 2027
Study Completion Date
April 30, 2030
Immediate Azathioprine (1st attack)
"Patients randomized in Immediate Azathioprine group will benefit from immediate treatment with azathioprine. Treatment will be started at 2mg/kg or at 1mg/kg if the patient has a partial activity which would be increased slowly according the 6-TGN activity and clinical and biological tolerance at Week 2 for patient with partial activity or M1 for patient without TPMT activity deficit.~Only for patient with partial deficit and whose 6-TGN activity is low, azathioprine would be increased at 3mg/kg/d at Week 6 and without exceeding a total daily dose of 150 mg."
Immediate Rituximab (1st attack)
"Patients randomized in Immediate Rituximab group will benefit from immediate treatment with rituximab. Rituximab 375mg/m2 IV will be given at D1 and D15 and repeat every 6 months for 2 years.~Once the inclusion criteria are validated, the first injection will be performed according to the injection protocol (Annex 4). Fifteen day later, the second injection will be performed.~The next visit during a consultation with PI or his collaborators will be scheduled 1 week ± 2 days later, and patients will be advised to contact the PI if any neurologic symptoms or symptoms of adverse event occurs in the meantime."
Standard of care
Patients in this group will be treated according to standard care
RECRUITING
Hôpital Bicêtre, Le Kremlin-Bicêtre
NOT_YET_RECRUITING
CHU Besançon, Besançon
NOT_YET_RECRUITING
CHU Bordeaux, Bordeaux
NOT_YET_RECRUITING
CHU Brest, Brest
NOT_YET_RECRUITING
HCL de Bron, Bron
NOT_YET_RECRUITING
CHRU Lille, Lille
NOT_YET_RECRUITING
CHU Monptellier, Montpellier
NOT_YET_RECRUITING
CHU Strasbourg, Strasbourg
NOT_YET_RECRUITING
CHU Toulouse Purpan, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER