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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01400503
Registration number
NCT01400503
Ethics application status
Date submitted
21/04/2011
Date registered
22/07/2011
Date last updated
22/05/2018
Titles & IDs
Public title
A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
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Scientific title
An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Subjects With Multicentric Castleman's Disease
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Secondary ID [1]
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CNTO328MCD2002
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Secondary ID [2]
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CR018469
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multicentric Castleman's Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Siltuximab
Experimental: Siltuximab - Siltuximab 11 mg/kg, intravenous infusion, given as a 1-hour infusion every 3 weeks.
Treatment: Drugs: Siltuximab
Type=exact number, unit=mg/kg, number=11, form=intravenous solution, route=intravenous. Siltuximab given as a 1-hour infusion every 3 weeks.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events (AEs)
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Assessment method [1]
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An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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Timepoint [1]
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Up to 6 years
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Secondary outcome [1]
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Percentage of Previously Responding Participants Who Maintained Disease Control
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Assessment method [1]
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Percentage of participants maintaining disease control (defined as stable or better response) was defined as the percentage of previously responding participants who had not progressed during the long-term safety extension based on investigator assessment. A worsening in any of the measures will be considered as a progression of the disease.
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Timepoint [1]
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Up to 6 years
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Secondary outcome [2]
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Percentage of Siltuximab-naive Participants Who Experienced Disease Control
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Assessment method [2]
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Percentage of participants experiencing disease control was defined as the percentage of siltuximab-naïve participants who had stable or better response during the long-term safety extension based on investigator's judgment. Disease control was defined as stable or better response assessed by the investigators.
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Timepoint [2]
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Up to 6 years
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Secondary outcome [3]
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Duration of Disease Control
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Assessment method [3]
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Duration of disease control (DODC) was defined as the time from the first siltuximab administration in this study to disease progression as assessed by the investigator. Disease control was defined as stable or better response assessed by the investigators. Kaplan-Meier method was used to estimate the duration of disease control.
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Timepoint [3]
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Up to 6 years
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall survival was defined as the time between the first study siltuximab administration and death due to any cause. Kaplan-Meier method was used to estimate the overall survival.
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Timepoint [4]
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Up to 6 years
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Secondary outcome [5]
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Number of Participants Positive for Antibodies to Siltuximab
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Assessment method [5]
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Serum samples were screened for antibodies binding to siltuximab and number of participants positive for antibodies to siltuximab was reported.
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Timepoint [5]
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Up to 6 years
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Eligibility
Key inclusion criteria
- Has multicentric Castleman's disease
- Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment
arm)
- Have had their last administration of study treatment (siltuximab or placebo) less
than 6 weeks (window of plus 2 weeks) prior to first dose
- Patients must not have had disease progression while receiving siltuximab. For those
patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have
received less than 4 months of siltuximab following crossover will also be eligible
- Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of
siltuximab for this study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of
consent as reason for discontinuing treatment from previous sponsor-initiated
siltuximab study
- Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study
- Known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies,
to murine, chimeric, human proteins or their excipients
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2017
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Sample size
Target
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Accrual to date
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Final
60
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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United States of America
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Florida
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United States of America
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Michigan
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United States of America
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North Carolina
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Washington
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Belgium
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State/province [8]
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Leuven
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Brazil
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Sao Paulo
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Canada
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Toronto
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China
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Beijing
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China
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Chengdu
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Egypt
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Cairo
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France
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Montpellier
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France
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Tours Cedex 9
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France
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Vandoeuvre Les Nancy
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Germany
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Berlin
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Hong Kong
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Sha Tin
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Israel
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Ramat Gan
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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Norway
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Oslo
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Singapore
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Singapore
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Spain
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Madrid
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Taiwan
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Taipei
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United Kingdom
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State/province [26]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the long-term safety of siltuximab in patients with
multicentric Castleman's disease (MCD).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01400503
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01400503
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