Condition: Granulomatosis With Polyangitis · Sponsor: Hospices Civils de Lyon
Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood of disease control and temporary remission. However, most patients have recurrent relapses that lead to damage and require repeated treatment associated with long-term morbidity and death. Rituximab has been shown to be as effective as cyclophosphamide to induce remission and maintenance of remission in severe GPA and MPA patients, with an acceptable safety profile . Although rituximab is becoming the standard of care for maintenance therapy in these patients, relapse still occurs and the optimal duration of prednisone therapy remains debated. On the one hand, most US studies use early withdrawal (6-12 months) because of feared side effects. On the other hand, most European trials propose late withdrawal (\>18 months) given a lower observed relapse rate on long-term low dose glucocorticoids treatment. In a systematic review and meta-analysis, glucocorticoids regimen was the most significant variable explaining the variability between the proportions of ANCA-associated vasculitis patients with relapses. Nevertheless, it was an indirect estimation of treatment effect because of the absence of dedicated randomized trial. This meta-analysis concluded that combined longer-term (i.e. \>12 months) use of low dose prednisone or nonzero glucocorticoids target is associated with a 20% reduction of relapse comp…
This description comes directly from the study's public registry record.
Jean-Christophe LEGA, Pr · 04.78.86.19.79 · jean-christophe.lega@chu-lyon.fr
Xavier Puéchal, Dr · 01.58.41.32.41 · xavier.puechal@aphp.fr
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| CHU Amiens-Hôpital Nord | Amiens, France | Recruiting |
| CHU Angers | Angers, France | Recruiting |
| Clinique Rhône-Durance | Avignon, France | Not Yet Recruiting |
| Hôpital Jeanne d'Arc | Bar-le-Duc, France | Not Yet Recruiting |
| Hôpital Avicenne | Bobigny, France | Not Yet Recruiting |
| Hôpital La Cavale Blanche | Brest, France | Recruiting |
| Hôpital Louis Pradel | Bron, France | Recruiting |
| CHU de Caen - Cote de Nacre | Caen, France | Recruiting |
| Hôpital Louis Pasteur | Chartres, France | Not Yet Recruiting |
| CHU Estaing | Clermont-Ferrand, France | Recruiting |
| CHU Gabriel Montpied | Clermont-Ferrand, France | Recruiting |
| CHIC Créteil | Créteil, France | Not Yet Recruiting |
+ 33 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03290456