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Complete title: An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Subjects with Multicentric Castlemans Disease
|Research Study Number||2502.00|
|Principal Investigator||Corey Casper|
Research Study Description
The purpose of this study is to assess the safety of extended treatment with siltuximab in patients who were previously enrolled in sponsor-initiated studies of multicentric Castleman's disease (C0328T03 and CNTO328MCD2001) and are either treatment-naive or have not progressed on siltuximab in the opinion of the investigator.
Eligibility Criteria (must meet the following to participate in this study)
- 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 with longer treatment durations since the last study treatment may be allowed after discussion with the medical monitor
- 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study
- Intervening treatment for Castleman's disease since the previous siltuximab study except for corticosteroids, provided the dose is not exceeding 1 mg/kg/day of prednisone (or equivalent) and remained stable or decreased over the 4 weeks prior to enrollment
- Known unmanageable allergies, hypersensitivity, or intolerance to monoclonal antibodies or to murine, chimeric, or human proteins or their excipients
Other exclusion criteria may apply.
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