Microscopic Polyangiitis Clinical Trial
Official title:
MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis
Study of the efficacy of rituximab for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of rituximab versus azathioprine
Randomized, controlled, national, multicenter, prospective study to compare between azathioprine (conventional therapy) and rituximab in patients with systemic ANCA-associated vasculitis, in remission (achieved with an induction treatment combining corticosteroids and an immunosuppressant, mainly intravenous pulses of cyclophosphamide, and plasma exchanges and/or polyvalent immunoglobulins when indicated) after the first flare of the disease (new diagnosis) or after a relapse. It is planned to stratify patients by first flare (66% of the patients) or relapse (33% of the patients). Patients complying with the inclusion criteria may be included when they are in remission from their vasculitis. Patients who have already received biologics (antiCD20, antiTNFα) will not be included. Patients will be included at the time of remission and then randomized. They will receive maintenance treatment by azathioprine for 18 months or a rituximab infusion every 6 months until month 18 (i.e. a total of 4 infusions), at the dose of 375 mg/m2 (maximum dosage, 500 mg). ANCA status and CD19+ lymphocyte count will be monitored but will not be used to adjust therapy. After the 18 month length of maintenance phase, i.e. after stopping immunosuppressive maintenance therapy, patients will be followed for an additional 10 month period. Patients with Wegener's granulomatosis will be prescribed cotrimoxazole 160/800 tid (for 2 additional years). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01729624 -
PRO Development for ANCA Associated Vasculitis
|
N/A | |
Terminated |
NCT02474888 -
Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
|
||
Active, not recruiting |
NCT02198248 -
Low-dose Glucocorticoid Vasculitis Induction Study
|
Phase 4 | |
Completed |
NCT02190916 -
Vasculitis Illness Perception (VIP) Study
|
N/A | |
Recruiting |
NCT01241305 -
One-Time DNA Study for Vasculitis
|
||
Recruiting |
NCT02967068 -
VCRC Tissue Repository
|
||
Completed |
NCT01731561 -
Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis
|
Phase 3 | |
Not yet recruiting |
NCT06350110 -
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
|
Phase 1/Phase 2 | |
Completed |
NCT02190942 -
VCRC Patient Contact Registry Patient-Reported Data Validation Study
|
||
Not yet recruiting |
NCT02126098 -
Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis
|
N/A | |
Terminated |
NCT01586858 -
Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study
|
N/A | |
Completed |
NCT00307593 -
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
|
N/A | |
Completed |
NCT02190929 -
Educational Needs of Patients With Systemic Vasculitis
|
N/A | |
Terminated |
NCT01408836 -
Plasma Exchange for Renal Vasculitis
|
Phase 2/Phase 3 | |
Terminated |
NCT05376319 -
PR3-AAV Resilient Remission or PRRR
|
Phase 2 | |
Completed |
NCT02476292 -
Impact of Vasculitis on Employment and Income
|
N/A | |
Completed |
NCT02169219 -
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
|
Phase 4 | |
Completed |
NCT01613599 -
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
|
||
Active, not recruiting |
NCT05716334 -
Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator
|
||
Completed |
NCT00307671 -
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
|
Phase 4 |