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NCT01024036 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
NCT01024036: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT01024036 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 79 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01024036, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.
Primary Outcome
Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: \>=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at
Interventions
- DRUG Placebo
- DRUG Siltuximab
- DRUG Best Supportive Care (BSC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2010-03-18 |
| Est. Completion | 2017-02-24 |
| Phase | Phase 2 |
What the finished NCT01024036 record still lists
NCT01024036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01024036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01024036 about?
NCT01024036 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease". The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.
What is the current status of trial NCT01024036?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2010-03-18. Estimated completion is 2017-02-24.
What interventions are being tested in trial NCT01024036?
The interventions under investigation include: Placebo (DRUG), Siltuximab (DRUG), Best Supportive Care (BSC) (DRUG).
Who is sponsoring clinical trial NCT01024036?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01024036's enrollment target sits among peer trials
79 884th of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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