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NCT01513317 · ClinicalTrials.gov registry record · Phase 2
A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome
A Phase 2 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT01513317: Clinical Trial Phase 2 study, sponsored by Janssen Research & Development.
NCT01513317 is a Phase 2 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01513317, a Phase 2 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic Syndrome (MDS).
Primary Outcome
Reduction in RBC transfusions to treat the anemia of MDS is defined as a ≥50 percentage relative decrease and a ≥2 unit absolute decrease in RBC transfusions in the 8 weeks before the unblinding (scheduled to occur after 12 weeks of treatment) compared with RBC transfusions in the 8 weeks before the date the informed consent form was signed.
Interventions
- DRUG Placebo
- DRUG Siltuximab
- DRUG Best supportive care (BSC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
Why NCT01513317 stopped before completion
NCT01513317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01513317 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01513317 about?
NCT01513317 is a clinical study titled "A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome". The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic Syndrome (MDS).
What is the current status of trial NCT01513317?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2011-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01513317?
The interventions under investigation include: Placebo (DRUG), Siltuximab (DRUG), Best supportive care (BSC) (DRUG).
Who is sponsoring clinical trial NCT01513317?
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 NCT01513317's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 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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