CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
Siltuximab +2 moredrug
Likely dose
Siltuximab 11 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01024036
NCT01024036Phase 2Completed
CompareCT.gov

A Randomized, 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

Janssen Research & Development, LLC·interventional·Posted Dec 2, 2009·Updated Mar 21, 2018

In Brief

A Phase 2 clinical trial evaluating Siltuximab, Placebo, and 1 other intervention for Multicentric Castleman's Disease. Completed, enrolled 79 participants across 56 sites in 23 countries.

Detailed Summary

The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMulticentric Castleman's Disease
CountriesAustralia, Belgium, Brazil, Canada, China, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Malaysia, Netherlands, New Zealand, Norway, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2009
Enrollment StartMar 18, 2010
Primary CompletionMar 25, 2013
Study CompletionFeb 24, 2017
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 16.6 years ago

Interventions

Siltuximabdrug

Siltuximab 11 mg/kg will be administered by 1-hour intravenous infusion every 3 weeks

Placebodrug

Placebo will be administered by 1-hour intravenous infusion every 3 weeks

Best Supportive Care (BSC)drug

BSC included treatment for effusions, antipyretics, antipuretics, antihistamines, pain medication, treatment for infections, transfusions, management of infusion-related reactions, and corticosteroids.