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Trial record 3 of 5 for:    "Unicentric Castleman Disease" | "Antibodies"

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

Tracking Information
First Submitted Date  ICMJE April 21, 2011
First Posted Date  ICMJE July 22, 2011
Results First Submitted Date  ICMJE March 1, 2018
Results First Posted Date  ICMJE March 29, 2018
Last Update Posted Date May 22, 2018
Actual Study Start Date  ICMJE April 1, 2011
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 6 years ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
The occurrence of adverse events [ Time Frame: Up to 4 years ]
Change History Complete list of historical versions of study NCT01400503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
  • Percentage of Previously Responding Participants Who Maintained Disease Control [ Time Frame: Up to 6 years ]
    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.
  • Percentage of Siltuximab-naive Participants Who Experienced Disease Control [ Time Frame: Up to 6 years ]
    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.
  • Duration of Disease Control [ Time Frame: Up to 6 years ]
    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.
  • Overall Survival [ Time Frame: Up to 6 years ]
    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.
  • Number of Participants Positive for Antibodies to Siltuximab [ Time Frame: Up to 6 years ]
    Serum samples were screened for antibodies binding to siltuximab and number of participants positive for antibodies to siltuximab was reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
  • The Multicentric Castleman's Disease Symptom Scale (MCDSS) as a measure of the severity of symptoms [ Time Frame: Up to 12 weeks ]
  • Pharmacodynamic assessments of interleukin-6 (IL-6) [ Time Frame: Up to 4 years ]
  • Glycoform clearance [ Time Frame: Up to 6 weeks ]
  • In vivo protein degradation analysis [ Time Frame: Up to 6 weeks ]
  • Proportion of previously responding patients and siltuximab-naive patients who maintain disease control [ Time Frame: Up to 4 years ]
  • Duration of disease control and survival [ Time Frame: Up to and after the 4-year data cutoff ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
Official Title  ICMJE An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Subjects With Multicentric Castleman's Disease
Brief Summary The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castleman's disease (MCD).
Detailed Description This is an open-label (all people know the identity of the intervention), multicenter (study conducted in multiple sites), non-randomized (patients are not assigned by chance to treatment groups), Phase 2b study. Up to 75 patients with MCD will be eligible for the study, the majority of whom will be on active therapy with siltuximab at the time of enrollment. Patients will be either siltuximab-naive or have not progressed on siltuximab in the opinion of the investigator. Duration of disease control and survival will be assessed. Data collection for patients who discontinue treatment will be limited to survival, occurrence of malignancies, and subsequent therapies for MCD, which will be assessed twice per year until the patient has been lost to follow up or has withdrawn consent for the study, whichever occurs first. An interim analysis will be conducted (no later than 2 years after the start of enrollment) to further evaluate the benefit and safety of long-term treatment with siltuximab in patients with MCD. A data will occur at 6 years after the start of enrollment and for those patients remaining on treatment after the data cutoff, data collection will be limited to pregnancies and serious adverse events (SAEs), including information on study agent administration and concomitant medications associated with an SAE. Safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study. The end of study is the date of the last assessment for the last patient.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multicentric Castleman's Disease
Intervention  ICMJE Drug: Siltuximab
Type=exact number, unit=mg/kg, number=11, form=intravenous solution, route=intravenous. Siltuximab given as a 1-hour infusion every 3 weeks.
Study Arms  ICMJE Experimental: Siltuximab
Siltuximab 11 mg/kg, intravenous infusion, given as a 1-hour infusion every 3 weeks.
Intervention: Drug: Siltuximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2011)
83
Actual Study Completion Date  ICMJE March 1, 2017
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Canada,   China,   Egypt,   France,   Germany,   Hong Kong,   Israel,   Korea, Republic of,   New Zealand,   Norway,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01400503
Other Study ID Numbers  ICMJE CR018469
CNTO328MCD2002 ( Other Identifier: Janssen Research & Development, LLC )
2010-022837-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP