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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

Brief Summary:
The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castleman's disease (MCD).

Condition or disease Intervention/treatment Phase
Multicentric Castleman's Disease Drug: Siltuximab Phase 2

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subsequent therapies for MCD, which will be assessed twice per year until the patient has been lost to follow up or has withdrawn consent for the study, whichever occurs first.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 : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Subjects With Multicentric Castleman's Disease
Actual Study Start Date : April 1, 2011
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017


Arm Intervention/treatment
Experimental: Siltuximab
Siltuximab 11 mg/kg, intravenous infusion, given as a 1-hour infusion every 3 weeks.
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400503


  Hide Study Locations
Locations
United States, Arkansas
Little Rock, Arkansas, United States
United States, Florida
Tampa, Florida, United States
United States, Michigan
Lansing, Michigan, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, South Carolina
Greenville, South Carolina, United States
United States, Texas
Houston, Texas, United States
United States, Washington
Seattle, Washington, United States
Belgium
Leuven, Belgium
Brazil
Sao Paulo, Brazil
Canada
Toronto, Canada
China
Beijing, China
Chengdu, China
Egypt
Cairo, Egypt
France
Montpellier, France
Tours Cedex 9, France
Vandoeuvre Les Nancy, France
Germany
Berlin, Germany
Hong Kong
Sha Tin, Hong Kong
Israel
Ramat Gan, Israel
Korea, Republic of
Seoul, Korea, Republic of
New Zealand
Auckland, New Zealand
Norway
Oslo, Norway
Singapore
Singapore, Singapore
Spain
Madrid, Spain
Taiwan
Taipei, Taiwan
United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Study Protocol  [PDF] April 4, 2014
Statistical Analysis Plan  [PDF] March 21, 2017


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 Posted: July 22, 2011    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: May 22, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Multicentric Castleman's Disease
Multicentric
Castleman
Siltuximab
Long term safety

Additional relevant MeSH terms:
Giant Lymph Node Hyperplasia
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Siltuximab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs