Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosi… (NCT03164473) | Clinical Trial Compass
CompletedPhase 3
Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis.
France98 participantsStarted 2018-03-07
Plain-language summary
The purpose of this study is to investigate, after achievement of remission, the efficacy of rituximab compared with azathioprine maintenance therapy on duration of remission, in patients with relapsing or newly-diagnosed Eosinophilic granulomatosis with polyangiitis EPGA receiving standard of care therapy including glucocorticoid therapy reduction/withdrawal.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients with a diagnosis of EGPA according to Lanham and/or ACR 1990 criteria and/or Revised Chapel Hill Nomenclature and/or MIRRA study inclusion criteria
* 18 years of age or more
* with newly-diagnosed EGPA or after a vasculitis flare and remission achieved within the past year
* independently of ANCA status
* within 30-360 days following achievement of vasculitis remission (corresponding to a Birmingham Vasculitis Activity Score (BVAS)=0) achieved with an induction regimen including the one used in the REOVAS trial: either CS alone or in association with CYC (total dose ranging from 4.5-10 g for patients \<65 years old and from 3-10g for patients ≥65 years old) or RTX (2 x 1g (D1, D15) or 4 weekly 375 mg/m2).
* with a stable prednisone dose for 30 days or no more prednisone
* after oral immunosuppressive drug cessation if started at remission.
* Patients included in the REOVAS trial and achieving remission can be included at month 12 visit if they fulfil the other criteria
* Patients able to give written informed consent prior to participation in the study.
* Affiliation with a mode of social security (profit or being entitled).
Exclusion Criteria:
* patients with GPA, MPA or other vasculitides
* patients with vasculitis not in remission defined as a BVAS \>0
* acute or chronic active infections (including HIV, HBV or HCV)
* active or recent cancer ( \<5 years), except basocellular carcinoma and low activity prostatic cancer controlled by hormona…