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A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease

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ClinicalTrials.gov Identifier: NCT01400503
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : March 29, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multicentric Castleman's Disease
Intervention: Drug: Siltuximab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants enrolled in this study CNTO328MCD2002 included participants who were previously enrolled in study C0328T03 (NCT00412321) or CNTO328MCD2001 (NCT01024036) (either placebo or siltuximab treatment arm). A total of 60 participants from previous MCD studies C0328T03 and CNTO328MCD2001 were found eligible to be enrolled in this study.

Reporting Groups
  Description
Siltuximab Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.

Participant Flow:   Overall Study
    Siltuximab
STARTED   60 
COMPLETED   0 
NOT COMPLETED   60 
Withdrawal by Subject                1 
Study Terminated by Sponsor                58 
Other                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Siltuximab Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.

Baseline Measures
   Siltuximab 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.1  (14.51) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      20  33.3% 
Male      40  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      5   8.3% 
Not Hispanic or Latino      55  91.7% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   1.7% 
Asian      23  38.3% 
Native Hawaiian or Other Pacific Islander      2   3.3% 
Black or African American      3   5.0% 
White      31  51.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Asian   23 
Black or African American   3 
Hispanic or Latino   5 
Other   3 
White Non-Hispanic   26 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
Belgium   1 
Brazil   1 
Canada   1 
China   6 
Egypt   1 
France   3 
Germany   1 
Hong Kong   3 
New Zealand   2 
Norway   2 
Singapore   3 
Korea, Republic Of   4 
Spain   2 
Taiwan, Province Of China   1 
United Kingdom   2 
United States   27 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Up to 6 years ]

2.  Secondary:   Percentage of Previously Responding Participants Who Maintained Disease Control   [ Time Frame: Up to 6 years ]

3.  Secondary:   Percentage of Siltuximab-naive Participants Who Experienced Disease Control   [ Time Frame: Up to 6 years ]

4.  Secondary:   Duration of Disease Control   [ Time Frame: Up to 6 years ]

5.  Secondary:   Overall Survival   [ Time Frame: Up to 6 years ]

6.  Secondary:   Number of Participants Positive for Antibodies to Siltuximab   [ Time Frame: Up to 6 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Leader
Organization: Janssen Research & Development, LLC
phone: 844-434-4210
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01400503     History of Changes
Other Study ID Numbers: CR018469
CNTO328MCD2002 ( Other Identifier: Janssen Research & Development, LLC )
2010-022837-27 ( EudraCT Number )
First Submitted: April 21, 2011
First Posted: July 22, 2011
Results First Submitted: March 1, 2018
Results First Posted: March 29, 2018
Last Update Posted: May 22, 2018