NCT01920477 - Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 13, 2013

Primary Completion Date

April 13, 2016

Study Completion Date

January 11, 2018

Conditions

Pemphigus Vulgaris

Interventions

BIOLOGICAL

Ofatumumab

Ofatumumab (human monoclonal antibody) was provided in prefilled glass syringes initial syringes contained 0.6ml (60mg) of concentration 100 mg/m: drug product subsequently modified to 0.4 mL (20mg) concentration (50mg/ML) drug product

BIOLOGICAL

Placebo

Placebo to match the active doses will consist of prefilled glass syringes filled with normal saline.

Trial Locations (16)

3002

Novartis Investigational Site, East Melbourne

3050

Novartis Investigational Site, Melbourne

14203

Novartis Investigational Site, Buffalo

15213

Novartis Investigational Site, Pittsburgh

20122

Novartis Investigational Site, Milan

27710

Novartis Investigational Site, Durham

30322

Novartis Investigational Site, Atlanta

48103

Novartis Investigational Site, Ann Arbor

52621

Novartis Investigational Site, Ramat Gan

54643

Novartis Investigational Site, Thessaloniki

64239

Novartis Investigational Site, Tel Aviv

84132

Novartis Investigational Site, Salt Lake City

90045

Novartis Investigational Site, Los Angeles

400006

Novartis Investigational Site, Cluj-Napoca

160-8582

Novartis Investigational Site, Tokyo

02-008

Novartis Investigational Site, Warsaw