Evaluation of Glucocorticoids Plus Rituximab in Patients With Newly-Diagnosed or Relapsing IgA Vasculitis

Exclusion Criteria

• •Patients with ANCA-associated vasculitis, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
• •Patients with IgAV in remission of the disease,
• •Patients with severe cardiac failure defined as class IV in New York Heart Association,
• •Patients with severe, uncontrolled cardiac disease,
• •Patients with acute infections or chronic active infections (including HIV, HBV or HCV),
• •Patients with active cancer or recent malignancy (\<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment,
• •Pregnant women and breastfeeding. Patients with childbearing potential must use reliable contraceptive methods throughout the study and at least for 12 months after the last study drug administration,
• •Patients with IgAV who have already been treated with rituximab within the previous 12 months,
• •Patients treated with immunosuppressive therapy within the last 3 months,
• •Patients with hypersensitivity to human or chimeric monoclonal antibodies,
• •Patients with contraindication to use rituximab,
• •Patients treated with any concomitant drugs contraindicated for use with the rituximab according to its SmPC,
• •Patients with contraindication to use routine care treatments (Glucocorticoids, Angiotensin-converting-enzyme (ACEis) or angiotensin receptor blockers (ARBs), dexchlorphéniramine),
• •Patients in a severely immunocompromised state,
• •Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric disorders, that could interfere with his/her compliance to protocol requirements,
• •Patients currently participating in another clinical study or 3 months prior to randomization,
• •Patients suspected not to be observant to the proposed treatments,
• •Patients unable to give written informed consent prior to participation in the study
• •Being deprived of liberty or under guardianship.