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Trial record 1 of 1 for:    MCD2001
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A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01024036
First Posted: December 2, 2009
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
Results First Submitted: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multicentric Castleman's Disease
Interventions: Drug: Siltuximab
Drug: Placebo
Drug: Best Supportive Care (BSC)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
79 participants were enrolled at 38 study centers in 19 countries. The first participant signed the informed consent on 09 Feb 2010, and the last participant's last visit for the primary analysis was 28 Feb 2013. The data for the primary analysis is presented here.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
79 participants were enrolled, randomized and treated during the blinded treatment period. 53 received siltuximab+best supportive care (BSC) and 26 received placebo+BSC.13 participants who did not respond to placebo+BSC during the blinded treatment period, received siltuximab+BSC during the unblinded treatment period.

Reporting Groups
  Description
Siltuximab + Best Supportive Care (BSC) 11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
Placebo + Best Supportive Care (BSC) Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC

Participant Flow for 2 periods

Period 1:   Blinded Treatment
    Siltuximab + Best Supportive Care (BSC)   Placebo + Best Supportive Care (BSC)
STARTED   53   26 
COMPLETED   31   6 
NOT COMPLETED   22   20 
Adverse Event                1                1 
Lack of Efficacy                16                14 
Physician Decision                1                0 
Death                0                2 
Withdrawal by Subject                4                3 

Period 2:   Unblinded Treatment
    Siltuximab + Best Supportive Care (BSC)   Placebo + Best Supportive Care (BSC)
STARTED   13 [1]   0 [2] 
COMPLETED   10   0 
NOT COMPLETED   3   0 
Adverse Event                1                0 
Lack of Efficacy                2                0 
[1] Only 13 participants from Placebo+BSC group received siltuximab+BSC in unblinded treatment period
[2] No participants received Placebo+BSC during unblinded treatment period



  Baseline Characteristics
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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 + Best Supportive Care (BSC) 11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
Placebo + Best Supportive Care (BSC) Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
Total Total of all reporting groups

Baseline Measures
   Siltuximab + Best Supportive Care (BSC)   Placebo + Best Supportive Care (BSC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   26   79 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.4  (13.32)   47.7  (13.4)   45.5  (13.35) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  43.4%      4  15.4%      27  34.2% 
Male      30  56.6%      22  84.6%      52  65.8% 
Region of Enrollment 
[Units: Participants]
     
AUSTRALIA   1   0   1 
BELGIUM   3   0   3 
BRAZIL   4   2   6 
CANADA   0   1   1 
CHINA   11   5   16 
EGYPT   0   1   1 
FRANCE   2   2   4 
GERMANY   0   1   1 
HONG KONG   3   2   5 
ISRAEL   1   1   2 
NEW ZEALAND   1   1   2 
NORWAY   1   1   2 
RUSSIAN FEDERATION   3   0   3 
SINGAPORE   3   0   3 
SOUTH KOREA   4   2   6 
SPAIN   1   1   2 
TAIWAN   3   1   4 
UNITED KINGDOM   2   1   3 
UNITED STATES   10   4   14 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review   [ Time Frame: From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from the study, or up to 48 weeks after the last participant started study medication, whichever occurred earlier ]

2.  Secondary:   Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review   [ Time Frame: From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment ]

3.  Secondary:   Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review   [ Time Frame: From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment ]

4.  Secondary:   Median Duration of Tumor Response - by Independent Radiology Review   [ Time Frame: From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment ]

5.  Secondary:   Time to Treatment Failure   [ Time Frame: From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment, whichever occurred earlier ]

6.  Secondary:   Percentage of Participants Who Achieved >= 15 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)   [ Time Frame: Week 13 ]

7.  Secondary:   Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)   [ Time Frame: Week 13 ]

8.  Secondary:   Percentage of Participants Who Discontinued Corticosteroids   [ Time Frame: From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment ]

9.  Secondary:   1-year Survival Rate   [ Time Frame: 1 year ]

10.  Secondary:   Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman’s Disease Symptom Scale (MCD-SS) Score From Baseline   [ Time Frame: From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment ]

11.  Secondary:   Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline   [ Time Frame: From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment ]

12.  Secondary:   Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline   [ Time Frame: From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: DIRECTOR CLINICAL RESEARCH
Organization: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01024036     History of Changes
Other Study ID Numbers: CR016705
CNTO328MCD2001 ( Other Identifier: Janssen Research & Development, LLC )
2009-012380-34 ( EudraCT Number )
First Submitted: November 30, 2009
First Posted: December 2, 2009
Results First Submitted: May 16, 2014
Results First Posted: August 20, 2014
Last Update Posted: September 28, 2017