drugset / Trial / NCT00748644
Efficacy Study of Two Treatments in the Remission of Vasculitis
Phase 3
Completed
117 enrolled
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Study of the efficacy of rituximab for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of rituximab versus azathioprine
Timeline
- Start
- 2008-10
- Primary completion
- 2013-03
- Completion
- 2013-06
Publications
- Results Pugnet G, Pagnoux C, Terrier B, Perrodeau E, Puechal X, Karras A, Khouatra C, Aumaitre O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quemeneur T, Blanchard-Delaunay C, Godmer P, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L, Guillevin L; French Vasculitis Study Group. Rituximab versus azathioprine for ANCA-associated vasculitis maintenance therapy: impact on global disability and health-related quality of life. Clin Exp Rheumatol. 2016 May-Jun;34(3 Suppl 97):S54-9. Epub 2016 Mar 25.
- Results Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaitre O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quemeneur T, Blanchard-Delaunay C, Godmer P, Puechal X, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L; French Vasculitis Study Group. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014 Nov 6;371(19):1771-80. doi: 10.1056/NEJMoa1404231.
- Romand X, Paclet MH, Chuong MV, Gaudin P, Pagnoux C, Guillevin L, Terrier B, Baillet A. Serum calprotectin and renal function decline in ANCA-associated vasculitides: a post hoc analysis of MAINRITSAN trial. RMD Open. 2023 Oct;9(4):e003477. doi: 10.1136/rmdopen-2023-003477.
- Terrier B, Pagnoux C, Perrodeau E, Karras A, Khouatra C, Aumaitre O, Cohen P, Decaux O, Desmurs-Clavel H, Maurier F, Gobert P, Quemeneur T, Blanchard-Delaunay C, Bonnotte B, Carron PL, Daugas E, Ducret M, Godmer P, Hamidou M, Lidove O, Limal N, Puechal X, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group. Long-term efficacy of remission-maintenance regimens for ANCA-associated vasculitides. Ann Rheum Dis. 2018 Aug;77(8):1150-1156. doi: 10.1136/annrheumdis-2017-212768. Epub 2018 May 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azathioprine | Small molecule | 2 mg/kg | — |
| Subject | Rituximab | Monoclonal antibody | 500 mg | — |