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
|Condition or disease||Intervention/treatment||Phase|
|Multicentric Castleman's Disease||Drug: Siltuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Siltuximab 11 mg/kg, intravenous infusion, given as a 1-hour infusion every 3 weeks.
Type=exact number, unit=mg/kg, number=11, form=intravenous solution, route=intravenous. Siltuximab given as a 1-hour infusion every 3 weeks.
- 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.
- 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.
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
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|