A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
|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.|
|ClinicalTrials.gov Identifier: NCT01400503|
Recruitment Status : Active, not recruiting
First Posted : July 22, 2011
Last Update Posted : January 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multicentric Castleman's Disease||Drug: Siltuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 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|
|Primary Completion Date :||March 1, 2017|
|Estimated Study Completion Date :||February 2, 2018|
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 Patients with Adverse Events [ Time Frame: Up to 6 years ]An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Number of multicentric Castleman's disease patients evaluated for assessment of atypical IL-6 splice variants or cleavage fragments [ Time Frame: Up to 6 years ]Pharmacodynamic biomarker evaluations include assessment of atypical IL-6 splice variants or cleavage fragments.
- Number of multicentric Castleman's disease patients evaluated for assessment of C-reactive protein [ Time Frame: Up to 6 years ]Pharmacodynamic biomarker evaluations include assessment of C-reactive protein.
- Number of previously responding multicentric Castleman's disease patients and siltuximab-naive patients who maintain disease control [ Time Frame: Up to 6 years ]Disease assessments (including cutaneous assessments), are provided as a guide for assessing multicentric Castleman's disease.
- Duration of multicentric Castleman's disease control [ Time Frame: Up to 6 years ]Disease assessments (including cutaneous assessments), are provided as a guide for assessing multicentric Castleman's disease.
- Duration of survival for patients with multicentric Castleman's disease [ Time Frame: From randomization up to death, lost to follow-up or withdrawal of consent, whichever come first; until 6 years ]Disease assessments (including cutaneous assessments), are provided as a guide for assessing multicentric Castleman's disease.
- Multicentric Castleman's Disease Symptom Scale scores [ Time Frame: Up to 12 weeks ]Multicentric Castleman's Disease Symptom Scale scores questionnaire will only be completed by the sub-population from the C0328T03 study. These scores will be calculated as a measure of severity of symptoms.
- Assessment of glycoform clearance analysis [ Time Frame: Up to 6 weeks ]For evaluating the clearance and degradation of glycoforms after administration of siltuximab, 6 serum samples will be collected from 5 former C0328T03 patients (a limited number of samples are needed for this analysis).
- Assessment of in vivo protein degradation analysis [ Time Frame: Up to 6 weeks ]Siltuximab will be isolated from the serum samples using an anti-Id antibody. The purified protein will be analyzed by liquid chromatography/mass spectroscopy techniques (intact mass and peptide mapping).
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
|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|
|Sao Paulo, Brazil|
|Tours Cedex 9, France|
|Vandoeuvre Les Nancy, France|
|Sha Tin, Hong Kong|
|Ramat Gan, Israel|
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Auckland, New Zealand|
|Manchester, United Kingdom|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|