Efficacy and Safety of CNTO328 in Multicentric Castleman's Disease
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman’s Disease
IRAS ID
27906
Contact name
Steve Schey
Sponsor organisation
Centocor B.V.
Eudract number
2009-012380-34
ISRCTN Number
NA
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to show that receiving CNTO 328 with best supportive care (BSC) will provide benefit compared to patients receiving BSC alone in patients with Multicentric Castleman??s Disease (MCD), a very rare disorder characterised by non-cancerous growths (tumours) that may develop in the lymph node tissue at a single site or throughout the body. Safety, additional efficacy measures and the pharmacokinetics of CNTO 328 will also be studied. Subjects will be treated (with placebo BSC or CNTO 328 BSC) every 3 weeks until treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last subject starts study treatment, whichever occurs earlier. Subjects who are benefiting from treatment at the end of study may continue to receive CNTO 328 in an extension protocol. Subjects who do not respond to placebo BSC will be treated with CNTO 328, in an unblinded treatment period, every 3 weeks until treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last subject starts study treatment, whichever occurs earlier. The study will end 48 weeks after the last subject starts study treatment. Survival will be followed-up until the study ends. Additional survival data will be obtained for subjects treated beyond the end of study in an extension protocol.
REC name
London - London Bridge Research Ethics Committee
REC reference
10/H0804/16
Date of REC Opinion
18 May 2010
REC opinion
Further Information Favourable Opinion