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

NCT01400503 | Completed Phase 2 Results

• 3 other identifiers: CR018469CNTO328MCD20022010-022837-27
• Study Type: interventional
• Target: 60
• Locations: 17 countries
• Sites: 26

Brief Summary

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

Conditions

Multicentric Castleman's Disease

Keywords

Multicentric Castleman's Disease; Multicentric; Castleman; Siltuximab; Long term safety

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Up to 6 years

Secondary Outcomes (5)

• Percentage of Previously Responding Participants Who Maintained Disease Control

  Up to 6 years

• Percentage of Siltuximab-naive Participants Who Experienced Disease Control

  Up to 6 years

• Duration of Disease Control

  Up to 6 years

• Overall Survival

  Up to 6 years

• Number of Participants Positive for Antibodies to Siltuximab

  Up to 6 years

Study Arms (1)

Siltuximab

EXPERIMENTAL

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

Drug: Siltuximab

Interventions

Siltuximab DRUG

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

Siltuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (26)

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Lansing, Michigan, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Greenville, South Carolina, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Toronto, Canada

Location

Unknown Facility

Beijing, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Cairo, Egypt

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Tours, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Shatin, Hong Kong

Location

Unknown Facility

Ramat Gan, Israel

Location

Unknown Facility

Auckland, New Zealand

Location

Unknown Facility

Oslo, Norway

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Multi-centric Castleman's Disease

Interventions

siltuximab

Results Point of Contact

• Title: Clinical Leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: July 22, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 22, 2018
• Results First Posted: March 29, 2018

Record last verified: 2018-04

Locations

IL (1); DE (1); KR (1); BE (1); US (7); CN (2); NO (1); TW (1); CA (1); NZ (1); FR (3); GB (1); EG (1); BR (1); HK (1); ES (1); SG (1)