A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)

PHASE3CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

May 26, 2015

Primary Completion Date

November 28, 2018

Study Completion Date

October 29, 2019

Conditions
Pemphigus Vulgaris
Interventions
DRUG

Mycophenolate Mofetil Placebo

MMF matching placebo will be administered orally Q12H.

DRUG

Mycophenolate Mofetil

MMF will be administered at a starting dose of 500 milligrams (mg) Q12H and the dose will be titrated to achieve a goal of 1 gram (gm) Q12H.

DRUG

Rituximab

Rituximab will be administered at a dose of 1000 mg via IV infusion.

DRUG

Rituximab Placebo

Rituximab matching placebo will be administered via IV infusion.

Trial Locations (68)

1500

Hospital Austral, Pilar, Pcia de Buenos Aires

1888

Centro de Investigaciones Médicas - CIM, San Juan Bautista

2217

St George Hospital, Kogarah, New South Wales

4102

Veracity Clinical Research, Woolloongabba

5500

Hospital Luis Lagomaggiore, Mendoza

10029

Icahn School of Medicine at Mount Sinai, New York

10126

S.C. Dermatologia 2 - Ambulatorio Malattie Rare, Turin

14203

Uni of NY and Roswell Cancer, Buffalo

18341

HaEmek MC, Afula

19104

Penn University, Philadelphia

23538

University Hospital Schleswig-Holstein, Lübeck

25123

ASST DEGLI SPEDALI CIVILI DI BRESCIA; Clinica Dermatologica, Brescia

27100

U.O. Dermatologia Dipartimento Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia

27104

Wake Forest Baptist Hospital Center for Dermatology Research, Winston-Salem

28007

Hosp. G. U Gregorio Marañón, Madrid

29010

Hospital de la Victoria, Málaga

31008

Clinica Universitaria de Navarra, Pamplona

31096

Rambam Medical Centre; Dept. of Dermatology, Haifa

33000

CHU Hopitaux de Bordeaux, CHU Hopitaux de Bordeaux

34093

Bezm-i Alem University Medical Faculty, Istanbul

Istanbul Uni Istanbul Medical Faculty, Istanbul

34668

Haydarpasa Numune Training and Research Hospital, Istanbul

35033

CHU de Rennes - Hopital de Pontchaillo, Rennes

35294

University of Alabama Birmingham, Birmingham

42055

CHU Saint Etienne - Hôpital Nord, Saint-Etienne

44195

Cleveland Clinic, Cleveland

45040

Celal Bayar University Medical Faculty Hafsa Sultan Hospital, Manisa

48149

University of Munster, Münster

49100

Rabin Medical Centre; Dept. of Dermatology, Petah Tikva

50125

Ambulatorio di Malattie Rare e Immunopatologia Cutanea, Florence

50937

Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Köln, Cologne

51100

CHU de Reims, Reims

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik, Mainz

55455

University of Minnesota, Minneapolis

59037

Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez, Lille

60611

Northwestern University, Chicago

63104

St Louis University Hospital, St Louis

69120

Universitätsklinikum Heidelberg, Heidelberg

69495

Les Hospices Civils de Lyon Dermatologie inflammatoire et médecine interne, Lyon / Pierre Bénite

76031

CHU de Rouen - Hôpital Charles Nicolle, Rouen

79104

Kompetenzzentrum Fragile Haut Klinik fur Dermatologie und Venerologie, Freiburg im Breisgau

85724

University of Arizona Medical Research Office, Tucson

90502

Los Angeles Biomedical Research Institute, Torrance

93000

Department of Dermatology Avicenne Hospital & University, Bobigny

94115

Univ of Calif-San Francisco, San Francisco

95816

UC Davis Department of Dermatology, Sacramento

97239

Oregon Health Sciences Uni, Portland

5262100

Sheba Medical Center, Ramat Gan

6423906

Sourasky Medical Centre, Tel Aviv

02114

Massachusetts General Hospital Dermatology, Boston

C1181ACH

Hospital Italiano, Buenos Aires

18618-970

Faculdade de Medicina de Botucatu - Hospital das Clínicas, Botucatu

01221-020

Santa Casa de São Paulo Hospital Central X, São Paulo

05403-000

Hospital das Clinicas - FMUSP, São Paulo

T6G 2G3

University of Alberta, Edmonton

V3R 6A7

Guildford Dermatology, Surrey

L3P 1X2

Lynde Institute for Dermatology, Markham

01304

University Hospital for Dermatology, Dresden

Unknown

Università di Parma Clinica Dermatologica, Parma

Gülhane Military Medical Academy in Ankara, Ankara

Gaziantep University Medical Faculty Sahinbey Hospital, Gaziantep

Marmara Uni, Istanbul

Karadeniz Teknik Üniversitesi Tıp Fakültesi Farabi Hastanesi, Trabzon

Dnipropetrovsk State Medical Academy, Dnipropterovsk

00167

Centro Clinico per le genodermatosi Dipartimento di Dermatologia dell'Immacolata - IRCCS, Rome

08036

Hospital Clínic. Barcelona, Barcelona

07059

Akdeniz University Medical Faculty, Antalya

01032

"Territorial Medical Association Dermatovenerologia", Kyiv

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY