Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01400503 | A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease | PHASE2 | COMPLETED | 60 | — | — | Apr 1, 2011 | Mar 1, 2017 | May 22, 2018 | 26 | United States, Belgium +15 |
| NCT01024036 | A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease | PHASE2 | COMPLETED | 79 | — | — | Mar 18, 2010 | Feb 24, 2017 | Mar 21, 2018 | 56 | United States, Australia +21 |
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.
Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: \>=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks. The statistical analysis shows difference in symptomatic response rate (siltuximab+best supportive care \[BSC\] minus Placebo+BSC).
| Arm | Type | Description |
|---|---|---|
| Siltuximab | EXPERIMENTAL | Siltuximab 11 mg/kg, intravenous infusion, given as a 1-hour infusion every 3 weeks. |
| Siltuximab+best supportive care (BSC) | EXPERIMENTAL | Siltuximab 11 mg/kg will be administered as a 1-hour intravenous infusion every 3 weeks + BSC. |
| Placebo+BSC | PLACEBO_COMPARATOR | Placebo will be administered as a 1-hour intravenous infusion every 3 weeks + BSC. Participants who do not respond to placebo during the blinded treatment period will have option to crossover and receive siltuximab 11 mg/kg which will be administered by 1-hour intravenous infusion every 3 weeks + BSC during the unblinded treatment period. |
| Name | Type | Description |
|---|---|---|
| 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. |
| Placebo | DRUG | Placebo will be administered by 1-hour intravenous infusion every 3 weeks |
| Best Supportive Care (BSC) | DRUG | BSC included treatment for effusions, antipyretics, antipuretics, antihistamines, pain medication, treatment for infections, transfusions, management of infusion-related reactions, and corticosteroids. |
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 * Pati...