Informations générales (source: ClinicalTrials.gov)
A Prospective, Multicentric, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis. (MAINEPSAN)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
août 2019
juin 2024
26 avril 2025
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 compared to early withdrawal (i.e. ≤12 months).
The relapse rate in patients with early glucocorticoids (10-12 months) withdrawal was
provided in two studies and was of 37 and 34%, respectively. By contrast, the relapse
rate in patients with late prednisone withdrawal (18-24 months) and receiving rituximab
as maintenance treatment was 14% at 24 months in the MAINRITSAN trial. Of note, the
decision to withdraw glucocorticoids after 18 months was left to physician's discretion
in this study and two thirds of the nonsevere relapses occurred when patients were off
prednisone.
The trial detailed here is the first prospective trial evaluating the length of
glucocorticoid administration as remission adjunctive treatment for patients with GPA or
MPA.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Antoine FROISSART | 29/03/2024 01:28:33 | Contacter | ||
| HOPITAL FOCH | Matthieu GROH | 05/05/2025 07:11:58 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Avicenne | Robin DHOTE, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Cochin | Xavier PUECHAL, Pr | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | Alexandre KARRAS, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Croix Rousse - 69004 - Lyon - France | Pascal SEVE, Pr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Lyon Sud - 69310 - Pierre-Bénite - France | Jean-Christophe LEGA, Pr | Contact (sur clinicalTrials) | |||
| CH Bretagne Atlantique - 56017 - Vannes - France | Pascal GODMER, MD | Contact (sur clinicalTrials) | |||
| CH de Troyes - 10003 - Troyes - France | Pascale CHAUVEAU-JOUVE, MD | Contact (sur clinicalTrials) | |||
| CH de Verdun - 55100 - Verdun - France | Assetou DIARRASOUBA, MD | Contact (sur clinicalTrials) | |||
| CH Lyon Sud - 69495 - Pierre-Bénite - France | Jean Christophe LEGA, Pr | Contact (sur clinicalTrials) | |||
| CH Valenciennes - 59322 - Valenciennes - France | Thomas QUEMENEUR, MD | Contact (sur clinicalTrials) | |||
| CHIC Créteil - 94010 - Créteil - France | Antoine FROISSART, MD | Contact (sur clinicalTrials) | |||
| CHRU Bretonneau - 37044 - Tours - France | Elisabeth DIOT, MD | Contact (sur clinicalTrials) | |||
| CHRU François Mitterrand - 21000 - Dijon - France | Jean-Michel REBIBOU, Pr | Contact (sur clinicalTrials) | |||
| CHRU Hautepierre - 67098 - Strasbourg - France | Jacques-Eric GOTTENBERG, Pr | Contact (sur clinicalTrials) | |||
| CHRU Lille - Hôpital Claude Huriez - 59037 - Lille - France | Eric HACHULLA, Pr | Contact (sur clinicalTrials) | |||
| CHRU Rennes - Hôpital Sud - 35200 - Rennes - France | Thomas LE GALLOU, MD | Contact (sur clinicalTrials) | |||
| CHU Amiens-Hôpital Nord - 80054 - Amiens - France | Jean SCHMIDT, MD | Contact (sur clinicalTrials) | |||
| CHU Angers - 49933 - Angers - France | Christian LAVIGNE, MD | Contact (sur clinicalTrials) | |||
| CHU de Caen - Cote de Nacre - 14033 - Caen - France | Nicolas MARTIN-SILVA, MD | Contact (sur clinicalTrials) | |||
| CHU de Nice - Hôpital Pasteur 2 - 06001 - Nice - France | Nathalie TIEULIE, MD | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - 86021 - Poitiers - France | Mathieu PUYADE, MD | Contact (sur clinicalTrials) | |||
| CHU Estaing - 63003 - Clermont-Ferrand - France | Marc RUIVARD, Pr | Contact (sur clinicalTrials) | |||
| CHU Gabriel Montpied - 63003 - Clermont-Ferrand - France | Olivier AUMAITRE, Pr | Contact (sur clinicalTrials) | |||
| CHU Nantes - Hôtel Dieu - 44093 - Nantes - France | Antoine NEEL, MD | Contact (sur clinicalTrials) | |||
| CHU Strasbourg - 67000 - Strasbourg - France | Vincent POINDRON, MD | Contact (sur clinicalTrials) | |||
| Clinique Rhône-Durance - 84000 - Avignon - France | Pierre GOBERT, MD | Contact (sur clinicalTrials) | |||
| Hôpital Charles Nicolle - 76031 - Rouen - France | Ygal BENHAMOU, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Conception - 13005 - Marseille - France | Noémie JOURDE CHICHE, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Edouard Herriot - 69137 - Lyon - France | Laurent JULLIARD, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Haut Lévêque - 33600 - Pessac - France | Jean-François VIALLARD, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Jeanne d'Arc - 55000 - Bar-le-Duc - France | Philippe EVON, MD | Contact (sur clinicalTrials) | |||
| Hôpital La Cavale Blanche - 29200 - Brest - France | Claire DE MOREUIL, MD | Contact (sur clinicalTrials) | |||
| Hôpital la Pitié Salpêtrière - 75013 - Paris - France | Patrice CACOUB, Pr | Contact (sur clinicalTrials) | |||
| Hôpital La Timone - 13385 - Marseille - France | Nicolas SCHLEINITZ, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Louis Pasteur - 28018 - Chartres - France | Richard DAMADE, MD | Contact (sur clinicalTrials) | |||
| Hôpital Louis Pradel - 69500 - Bron - France | Vincent COTTIN, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Saint Louis - 75475 - Paris - France | Alfred MAHR, Pr | Contact (sur clinicalTrials) | |||
| Hôpitaux de Brabois - 54511 - Vandœuvre-lès-Nancy - France | Rolland JAUSSAUD, MD | Contact (sur clinicalTrials) | |||
| Hopitaux Universaitaire de Strasbourg Hopitaux - Strasbourg - France | Thierry KRUMMEL, MD | Contact (sur clinicalTrials) | |||
| HP Site Belle Isle - 57045 - Metz - France | François MAURIER, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients with a diagnosis of MPA or GPA independently of ANCA status,
- Patient aged of 18 years or older,
- Patients with newly-diagnosed disease or relapsing disease at the time of screening,
with an inactive disease defined as a BVAS = 0,
- Patients receiving maintenance infusion of rituximab 500 mg at 6 and 12 months after
the start of vasculitis induction
- Patients receiving 5-10 mg/day of prednisone at screening,
- Patient able to give written informed consent prior to participation in the study.
- At Inclusion visit day, patient must be between 5 and 10 mg/day prednisone and at
randomization visit day (D1), patient must be at 5 mg/day prednisone
- Patients with a diagnosis of MPA or GPA independently of ANCA status,
- Patient aged of 18 years or older,
- Patients with newly-diagnosed disease or relapsing disease at the time of screening,
with an inactive disease defined as a BVAS = 0,
- Patients receiving maintenance infusion of rituximab 500 mg at 6 and 12 months after
the start of vasculitis induction
- Patients receiving 5-10 mg/day of prednisone at screening,
- Patient able to give written informed consent prior to participation in the study.
- At Inclusion visit day, patient must be between 5 and 10 mg/day prednisone and at
randomization visit day (D1), patient must be at 5 mg/day prednisone
- Patients with EGPA, or other vasculitides, defined by the ACR criteria and/or the
Chapel Hill Consensus Conference,
- Patients with vasculitis with active disease defined as a BVAS >0,
- Patients with acute infections or chronic active infections (including HIV, HBV or
HCV),
- Patients with active cancer or recent cancer (<5 years), except basocellular
carcinoma and prostatic cancer of low activity controlled by hormonal treatment,
- Pregnant women and lactation. Patients with childbearing potential should have
reliable contraception for the all duration of the study,
- Patients with other uncontrolled diseases, including drug or alcohol abuse, severe
psychiatric diseases, that could interfere with participation in the trial according
to the protocol,
- Patients included in other investigational therapeutic study within the previous 3
months,
- Patients suspected not to be observant to the proposed treatments,
- Patients who have white blood cell count ≤4,000/mm3,
- Patients who have platelet count ≤100,000/mm3,
- Patients who have ALT or AST level greater than 3 times the upper limit of normal
that cannot be attributed to underlying MPA-GPA disease,
- Patients unable to give written informed consent prior to participation in the
study.
- Patients with contraindication to use rituximab,