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

Phase 1

• Conditions: Multicentric Castleman's Disease; MedDRA version: 17.0Level: PTClassification code 10050251Term: Castleman's diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022837-27-DE
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-19
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

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 59
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the long-term safety of siltuximab in subjects with MCD.;Secondary Objective: - To determine the proportion of previously responding subjects who maintain disease control<br>- To determine the proportion of siltuximab-naive subjects who experience disease control<br>- To describe the duration of disease control and survival<br>- To assess reliability of a multicentric Castleman’s disease symptom scale (MCDSS)<br>- To evaluate IL-6 levels<br>- To assess formation of antibodies to siltuximab (immunogenicity) after long-term treatment in the MCD population;Primary end point(s): Proportion of patients for adverse events as a measure of safety;Timepoint(s) of evaluation of this end point: Up to 6 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Proportion of multicentric Castleman's disease (MCD) patients evaluated for pharmacodynamic biomarkers<br>- Proportion of previously responding MCD patients and siltuximab-naive patients who maintain disease control<br>- Duration of MCD disease control and survival<br>- Proportion of patients for Multicentric Castleman's Disease Symptom Scale (MCDSS) as a measure of the severity of symptoms<br>- Assessment of glycoform clearance analysis<br>- Assessment of in vivo protein degradation analysis;Timepoint(s) of evaluation of this end point: Up to 6 Years