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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

NCT01513317 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2014-09-29

Study results available
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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).

Conditions

Interventions

DRUG

Siltuximab

15 mg/kg administered as a 1-hour intravenous infusion every 4 weeks

DRUG

Placebo

Administered as a 1-hour intravenous infusion every 4 weeks

DRUG

Best supportive care (BSC)

Best supportive care according to local standards and guidelines

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Australia
  • Belgium
  • Netherlands
  • Russia
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513317 on ClinicalTrials.gov