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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01400503




Registration number
NCT01400503
Ethics application status
Date submitted
21/04/2011
Date registered
21/07/2011
Date last updated
25/04/2018

Titles & IDs
Public title
A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
Scientific title
An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Subjects With Multicentric Castleman's Disease
Secondary ID [1] 0 0
CNTO328MCD2002
Secondary ID [2] 0 0
CR018469
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multicentric Castleman's Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) - 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.
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [1] 0 0
Percentage of Previously Responding Participants Who Maintained Disease Control - 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.
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [2] 0 0
Percentage of Siltuximab-naive Participants Who Experienced Disease Control - 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.
Timepoint [2] 0 0
Up to 6 years
Secondary outcome [3] 0 0
Duration of Disease Control - 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.
Timepoint [3] 0 0
Up to 6 years
Secondary outcome [4] 0 0
Overall Survival - 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.
Timepoint [4] 0 0
Up to 6 years
Secondary outcome [5] 0 0
Number of Participants Positive for Antibodies to Siltuximab - Serum samples were screened for antibodies binding to siltuximab and number of participants positive for antibodies to siltuximab was reported.
Timepoint [5] 0 0
Up to 6 years

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
Canada
State/province [10] 0 0
Toronto
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Chengdu
Country [13] 0 0
Egypt
State/province [13] 0 0
Cairo
Country [14] 0 0
France
State/province [14] 0 0
Montpellier
Country [15] 0 0
France
State/province [15] 0 0
Tours Cedex 9
Country [16] 0 0
France
State/province [16] 0 0
Vandoeuvre Les Nancy
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Sha Tin
Country [19] 0 0
Israel
State/province [19] 0 0
Ramat Gan
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
New Zealand
State/province [21] 0 0
Auckland
Country [22] 0 0
Norway
State/province [22] 0 0
Oslo
Country [23] 0 0
Singapore
State/province [23] 0 0
Singapore
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Taiwan
State/province [25] 0 0
Taipei
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT01400503
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications