Trial · NCT04838860
Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease
NCT04838860, Phase 2, Terminated, RECORDATI GROUP
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease. Trials, record NCT04838860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04838860
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease
- NCT number
- NCT04838860
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- RECORDATI GROUP
- Conditions
- Idiopathic Multicentric Castleman's Disease
- Interventions
- Siltuximab
- First posted
- 2021-04-09
- Last updated
- 2021-04-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess the Clinical Benefit Response (CBR) of Siltuximab | 12 Weeks | Assess the clinical benefit response (CBR) of increased siltuximab doses in patients with IL-6-driven (C-reactive protein \[CRP\]-elevated and rising) idiopathic multicentric Castleman disease (iMCD) after disease progression on the standard siltuximab dose schedule. CBR defined as complete response (CR), partial response (PR), or stable disease (SD) lasting ≥12 weeks per Castleman Disease Collaborative Network Response Criteria (CDCNRC). |
| Secondary | To evaluate the safety and tolerability of increased Siltuximab doses | 12 Weeks | Incidence of Adverse Events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), incidence of abnormal laboratory test results incidence of dose-limiting toxicities (DLTs) |
| Secondary | Pharmacokinetics (Vd) | 12 Weeks | To test the patient's drug propensity |
| Secondary | Pharmacokinetics (CL) | 12 Weeks | To test the volume of plasma cleared of drug per unit time |
| Secondary | Pharmacokinetics (AUC) | 12 Weeks | To test the extent of exposure to a drug and its clearance rate from the body |
| Secondary | Pharmacokinetics (Cmin / Cmax) | 12 Weeks | To test the minimum (Cmin) and the maximum (Cmax) blood plasma concentration |
| Secondary | Pharmacokinetics (Ctrough) | 12 Weeks | To test the minimum drug concentration after a dose |
| Secondary | Pharmacokinetics (Tmax) | 12 Weeks | To test the time taken to reach Cmax |
| Secondary | Evaluate the efficacy of increased siltuximab doses after disease progression on prior siltuximab treatment. | 12 Weeks | The primary efficacy endpoint is CBR defined as CR, PR, or SD lasting ≥12 weeks per CDCNRC based on evaluation of biochemical, lymph node, and symptom response |
| Secondary | Evaluate the immunogenicity of increased siltuximab doses after disease progression on prior siltuximab treatment. | 12 Weeks | Immunogenicity will be assessed through the detection of antibodies against siltuximab, and will be conducted via immunoassay ± serum IL-6 levels on Day 1 of Cycle 1, 3, 6 and every 4 cycles thereafter, before administration of siltuximab. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04838860
GET https://conductscience.org/api/trials/v1/NCT04838860/registered