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

NCT ID: NCT01400503

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-01
• Study Completion Date: 2017-03-01

Brief Summary

The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castleman's disease (MCD).

Detailed Description

This is an open-label (all people know the identity of the intervention), multicenter (study conducted in multiple sites), non-randomized (patients are not assigned by chance to treatment groups), Phase 2b study. Up to 75 patients with MCD will be eligible for the study, the majority of whom will be on active therapy with siltuximab at the time of enrollment. Patients will be either siltuximab-naive or have not progressed on siltuximab in the opinion of the investigator. Duration of disease control and survival will be assessed. Data collection for patients who discontinue treatment will be limited to survival, occurrence of malignancies, and subsequent therapies for MCD, which will be assessed twice per year until the patient has been lost to follow up or has withdrawn consent for the study, whichever occurs first. An interim analysis will be conducted (no later than 2 years after the start of enrollment) to further evaluate the benefit and safety of long-term treatment with siltuximab in patients with MCD. A data will occur at 6 years after the start of enrollment and for those patients remaining on treatment after the data cutoff, data collection will be limited to pregnancies and serious adverse events (SAEs), including information on study agent administration and concomitant medications associated with an SAE. Safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study. The end of study is the date of the last assessment for the last patient.

Conditions

Multicentric Castleman's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Siltuximab

Siltuximab 11 mg/kg, intravenous infusion, given as a 1-hour infusion every 3 weeks.

Group Type: EXPERIMENTAL

Siltuximab

Intervention Type: DRUG

Type=exact number, unit=mg/kg, number=11, form=intravenous solution, route=intravenous. Siltuximab given as a 1-hour infusion every 3 weeks.

Interventions

Siltuximab

Type=exact number, unit=mg/kg, number=11, form=intravenous solution, route=intravenous. Siltuximab given as a 1-hour infusion every 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Has 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

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, intolerance to monoclonal antibodies, to murine, chimeric, human proteins or their excipients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Little Rock, Arkansas, United States

Tampa, Florida, United States

Lansing, Michigan, United States

Chapel Hill, North Carolina, United States

Greenville, South Carolina, United States

Houston, Texas, United States

Seattle, Washington, United States

Leuven, , Belgium

São Paulo, , Brazil

Toronto, , Canada

Beijing, , China

Chengdu, , China

Cairo, , Egypt

Montpellier, , France

Tours, , France

Vandœuvre-lès-Nancy, , France

Berlin, , Germany

Shatin, , Hong Kong

Ramat Gan, , Israel

Auckland, , New Zealand

Oslo, , Norway

Singapore, , Singapore

Seoul, , South Korea

Madrid, , Spain

Taipei, , Taiwan

Manchester, , United Kingdom

Countries

United States; Belgium; Brazil; Canada; China; Egypt; France; Germany; Hong Kong; Israel; New Zealand; Norway; Singapore; South Korea; Spain; Taiwan; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CNTO328MCD2002

Identifier Type: OTHER

Identifier Source: secondary_id

2010-022837-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR018469

Identifier Type: -

Identifier Source: org_study_id