Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 April 2019 |
Main ID: |
EUCTR2010-022837-27-GB |
Date of registration:
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01/08/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's Disease
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Scientific title:
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An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Subjects with Multicentric Castleman's Disease |
Date of first enrolment:
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15/02/2013 |
Target sample size:
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75 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022837-27 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Brazil
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Canada
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China
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Egypt
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France
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Germany
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Hong Kong
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Israel
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Korea, Republic of
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New Zealand
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Norway
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Singapore
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Spain
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+31(0)715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International N.V. |
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Name:
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Clinical Registry group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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+31(0)715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International N.V. |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Have multicentric Castleman's disease
- Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment arm)
- Have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose
- Patients must not have had disease progression while receiving siltuximab. For those patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have received less than 4 months of siltuximab following crossover will also be eligible
- Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of siltuximab for this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria: - Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of consent as reason for discontinuing treatment from previous sponsor-initiated siltuximab study
- Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study
- Known unmanageable allergies, hypersensitivity, or intolerance to monoclonal antibodies or to murine, chimeric, or human proteins or their excipients
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Multicentric Castleman's Disease
MedDRA version: 14.1
Level: PT
Classification code 10050251
Term: Castleman's disease
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: CNTO328 Product Code: CNTO328 Pharmaceutical Form: Powder for solution for infusion CAS Number: 541502-14-1 Current Sponsor code: CNTO328 Other descriptive name: SILTUXIMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100 and 400-
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Primary Outcome(s)
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Secondary Objective: - To determine the proportion of previously responding subjects who maintain disease control - To determine the proportion of siltuximab-naive subjects who experience disease control - To describe the duration of disease control and survival - To assess reliability of a multicentric Castleman’s disease symptom scale (MCDSS) - To evaluate IL-6 levels - To assess formation of antibodies to siltuximab (immunogenicity) after long-term treatment in the MCD population
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Main Objective: The primary objective is to evaluate the long-term safety of siltuximab in subjects with MCD.
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Primary end point(s): Proportion of patients for adverse events as a measure of safety
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Timepoint(s) of evaluation of this end point: Up to 5 years
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Secondary Outcome(s)
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Secondary end point(s): - Proportion of multicentric Castleman's disease (MCD) patients evaluated for pharmacodynamic biomarkers
- Proportion of previously responding MCD patients and siltuximab-naive patients who maintain disease control
- Duration of MCD disease control and survival
- Proportion of patients for Multicentric Castleman's Disease Symptom Scale (MCDSS) as a measure of the severity of symptoms
- Assessment of glycoform clearance analysis
- Assessment of in vivo protein degradation analysis
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Timepoint(s) of evaluation of this end point: Up to 5 Years
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Secondary ID(s)
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2010-022837-27-BE
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CNTO328MCD2002
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Ethics review
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Status: Approved
Approval date:
Contact:
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