Phase 2
N=60
A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
Multicentric Castleman's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01400503 ↗Enrolled (actual)
60
Serious AEs
41.7%
Results posted
Mar 2018
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Siltuximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
60 | — |
| SECONDARY Percentage of Previously Responding Participants Who Maintained Disease Control |
96.5 | — |
| SECONDARY Percentage of Siltuximab-naive Participants Who Experienced Disease Control |
100 | — |
| SECONDARY Duration of Disease Control |
NA | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Number of Participants Positive for Antibodies to Siltuximab |
3 | — |
Summary
The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castleman's disease (MCD).
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
Data sourced from ClinicalTrials.gov (NCT01400503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.