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

Completed · Phase 2

Conditions studied: Multicentric Castleman's Disease

In brief

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

Key facts

Study ID

NCT01400503

Run by

Janssen Research & Development, LLC

People needed

60

Starts

2011-04-01

Expected to finish

2017-03-01

Last updated by the study team

2018-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Tampa, Florida, United States
• Study site — Lansing, Michigan, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Greenville, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Leuven, Belgium
• Study site — São Paulo, Brazil
• Study site — Toronto, Canada
• Study site — Beijing, China
• Study site — Chengdu, China
• Study site — Cairo, Egypt
• Study site — Montpellier, France
• Study site — Tours, France
• Study site — Vandœuvre-lès-Nancy, France
• Study site — Berlin, Germany
• Study site — Shatin, Hong Kong
• Study site — Ramat Gan, Israel
• Study site — Auckland, New Zealand
• Study site — Oslo, Norway
• Study site — Singapore, Singapore
• Study site — Seoul, South Korea
• Study site — Madrid, Spain
• Study site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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