Innovative Anti-pneumococcal Vaccine Strategies in Patients With ANCA-associated Vasculitis Receiving Rituximab Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

February 5, 2018

Primary Completion Date

November 24, 2020

Study Completion Date

November 21, 2021

Conditions
Invasive Pneumococcal Infection
Interventions
BIOLOGICAL

PCV13

one dose of PCV13 at D0 (arm A) or two double doses at D0 and D7 (Arm B) or one quadruple dose at D0 (arm C)

BIOLOGICAL

PPV23

one dose of PPV23 at M5

DRUG

Rituximab

375 mg/m2/week for 4 consecutive weeks, at Days 0 ± 2 days, Day 7 ± 2 days, Day 14 ± 2 days and Day 21 ± 2 days, as induction therapy of vasculitis flare, followed by 500 mg-rituximab infusion every 6 months as maintenance therapy, i.e. at Month 6, Month 12 and Month 18

Trial Locations (1)

75014

"Pôle de Médecine Interne, Centre de référence Maladies systémiques et autoimmunes rares, en particulier Vascularites nécrosantes et Sclérodermies systémiques Hôpital Cochin, Assistance Publique-Hôpitaux de Paris", Paris

Sponsors
All Listed Sponsors
collaborator

EUCLID Clinical Trial Platform

OTHER

collaborator

Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

OTHER

collaborator

CIC 1417 Cochin-Pasteur

OTHER

collaborator

Groupe Français d'Etude des Vascularites (GFEV)

UNKNOWN

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT03069703 - Innovative Anti-pneumococcal Vaccine Strategies in Patients With ANCA-associated Vasculitis Receiving Rituximab Therapy | Biotech Hunter | Biotech Hunter