Trial · NCT01400503

A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease

NCT01400503, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2018-03-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease. Trials, record NCT01400503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01400503

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
NCT number: NCT01400503
Status: Completed
Phases: Phase 2
Enrollment: 60 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Multicentric Castleman's Disease
Interventions: Siltuximab
First posted: 2011-07-22
Last updated: 2018-05-22
Other registries' IDs: eudract:2010-022837-27
Results first posted: 2018-03-29

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events (AEs)	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	Percentage of Previously Responding Participants Who Maintained Disease Control	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.
Secondary	Percentage of Siltuximab-naive Participants Who Experienced Disease Control	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.
Secondary	Duration of Disease Control	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.
Secondary	Overall Survival	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.
Secondary	Number of Participants Positive for Antibodies to Siltuximab	Up to 6 years	Serum samples were screened for antibodies binding to siltuximab and number of participants positive for antibodies to siltuximab was reported.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events (AEs)	Up to 6 years	Safety analysis set included all enrolled participants in this study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Previously Responding Participants Who Maintained Disease Control	Up to 6 years	Population included subset of safety analysis set who previously responded to siltuximab treatment ie, did not report disease progression while receiving siltuximab in study C0328T03 or CNTO328MCD2001.	percentage of participants	NUMBER
SECONDARY	Percentage of Siltuximab-naive Participants Who Experienced Disease Control	Up to 6 years	Population included subset of safety analysis set who were previously Siltuximab-naive i.e., received placebo in study CNTO328MCD2001 and never received siltuximab prior to enrollment in this study.	percentage of participants	NUMBER
SECONDARY	Duration of Disease Control	Up to 6 years	Safety analysis set included all enrolled participants in this study.	years	MEDIAN
SECONDARY	Overall Survival	Up to 6 years	Safety analysis set included all enrolled participants in this study.	years	MEDIAN
SECONDARY	Number of Participants Positive for Antibodies to Siltuximab	Up to 6 years	Safety analysis set included all enrolled participants in this study.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Adverse Events (AEs)	Siltuximab	60		Participants
Percentage of Previously Responding Participants Who Maintained Disease Control	Siltuximab	96.5		percentage of participants
Percentage of Siltuximab-naive Participants Who Experienced Disease Control	Siltuximab	100		percentage of participants
Duration of Disease Control	Siltuximab	NA	95% Confidence Interval NA to NA	years
Overall Survival	Siltuximab	NA	95% Confidence Interval NA to NA	years
Number of Participants Positive for Antibodies to Siltuximab	Siltuximab	3		Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Siltuximab	60
Overall Study	COMPLETED	Siltuximab	0
Overall Study	NOT COMPLETED	Siltuximab	60

Source ClinicalTrials.gov

Adverse events271

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Siltuximab	7	60
other	Leukopenia	Blood and lymphatic system disorders	Siltuximab	5	60
other	Lymphadenopathy	Blood and lymphatic system disorders	Siltuximab	3	60
other	Lymphopenia	Blood and lymphatic system disorders	Siltuximab	3	60
other	Neutropenia	Blood and lymphatic system disorders	Siltuximab	9	60
other	Thrombocytopenia	Blood and lymphatic system disorders	Siltuximab	7	60
other	Atrioventricular Block First Degree	Cardiac disorders	Siltuximab	2	60
other	Cardiac Disorder	Cardiac disorders	Siltuximab	2	60
other	Palpitations	Cardiac disorders	Siltuximab	2	60
other	Ear Pain	Ear and labyrinth disorders	Siltuximab	6	60

1 to 10 of 271Source ClinicalTrials.gov

See all 271 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Siltuximab	0	60
Total, other adverse events	Siltuximab	60	60
Total, serious adverse events	Siltuximab	25	60

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01400503

GET https://conductscience.org/api/trials/v1/NCT01400503/events?page=2

API reference For AI assistants