drugset / Trial / NCT01731561
Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis
Phase 3
Completed
166 enrolled
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to assess the efficacy of a rituximab regimen based on rate of ANCA and CD19 lymphocytes for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of two rituximab regimens: one based on ANCA and CD19 lymphocytes versus systematic infusions.
Timeline
- Start
- 2012-11-16
- Primary completion
- 2016-04-05
- Completion
- 2016-04-05
Outcome
Missed primary endpoint
paper 14/81 (17.3%) in 13 tailored-infusion recipients and 8/81 (9.9%) in 8 fixed-schedule patients (p=0.22). PMID 29695500 ↗
paper AAV relapse rates did not differ significantly between individually tailored and fixed-schedule rituximab regimens. PMID 29695500 ↗
Publications
- Results Charles P, Terrier B, Perrodeau E, Cohen P, Faguer S, Huart A, Hamidou M, Agard C, Bonnotte B, Samson M, Karras A, Jourde-Chiche N, Lifermann F, Gobert P, Hanrotel-Saliou C, Godmer P, Martin-Silva N, Pugnet G, Matignon M, Aumaitre O, Viallard JF, Maurier F, Meaux-Ruault N, Riviere S, Sibilia J, Puechal X, Ravaud P, Mouthon L, Guillevin L; French Vasculitis Study Group. Comparison of individually tailored versus fixed-schedule rituximab regimen to maintain ANCA-associated vasculitis remission: results of a multicentre, randomised controlled, phase III trial (MAINRITSAN2). Ann Rheum Dis. 2018 Aug;77(8):1143-1149. doi: 10.1136/annrheumdis-2017-212878. Epub 2018 Apr 25.
- Khoudour N, Delestre F, Jabot-Hanin F, Jouinot A, Nectoux J, Letouneur F, Izac B, Vidal M, Guillevin L, Puechal X, Charles P, Terrier B, Blanchet B. Association Between Plasma Rituximab Concentration and the Risk of Major Relapse in Antineutrophil Cytoplasmic Antibody-Associated Vasculitides During Rituximab Maintenance Therapy. Arthritis Rheumatol. 2023 Nov;75(11):2003-2013. doi: 10.1002/art.42556. Epub 2023 Aug 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 500 mg | — |