drugset / Trial / NCT00647166
Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome)
Phase 3
Completed
114 enrolled
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
To determine whether a combination of corticosteroids and azathioprine can achieve a higher remission rate and a lower subsequent relapse rate in patients with newly-diagnosed microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) with no poor prognosis factor (FFS=0), and without significantly increasing the rate of adverse events, as compared to corticosteroids alone. The study hypothesis is a reduction of the absolute risk of treatment failure or relapse within the first 24 months following initiation of therapy of least 25%.
Timeline
- Start
- 2008-05
- Primary completion
- 2015-03
- Completion
- 2015-04
Publications
- Results Puechal X, Pagnoux C, Baron G, Quemeneur T, Neel A, Agard C, Lifermann F, Liozon E, Ruivard M, Godmer P, Limal N, Mekinian A, Papo T, Ruppert AM, Bourgarit A, Bienvenu B, Geffray L, Saraux JL, Diot E, Crestani B, Delbrel X, Sailler L, Cohen P, Le Guern V, Terrier B, Groh M, Le Jeunne C, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group. Adding Azathioprine to Remission-Induction Glucocorticoids for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss), Microscopic Polyangiitis, or Polyarteritis Nodosa Without Poor Prognosis Factors: A Randomized, Controlled Trial. Arthritis Rheumatol. 2017 Nov;69(11):2175-2186. doi: 10.1002/art.40205. Epub 2017 Oct 15.
- Puechal X, Pagnoux C, Baron G, Lifermann F, Geffray L, Quemeneur T, Saraux JL, Wislez M, Cottin V, Ruivard M, Limal N, Aouba A, Bonnotte B, Neel A, Agard C, Cohen P, Terrier B, Le Jeunne C, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group investigators. Non-severe eosinophilic granulomatosis with polyangiitis: long-term outcomes after remission-induction trial. Rheumatology (Oxford). 2019 Dec 1;58(12):2107-2116. doi: 10.1093/rheumatology/kez139.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azathioprine | Small molecule | 2 mg/kg | Oral |