Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT01400503
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01400503
Study Brief:
Protocol Section:
NCT01400503