Trial · NCT04838860
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | To evaluate the patient-reported outcomes (PROs) using the EQ-5D Instrument | 12 Weeks | The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D) has the following dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions |
| Secondary | To evaluate the patient-reported outcomes (PROs) using the MCD-SS Instrument | 12 Weeks | The Multicentric Castleman disease symptom score (MCD-SS) lists 10 symptoms which are graded on a scale: Did not experience (0); Very mild (2); Mild (4); Moderate (6); Severe (8); Very Severe (10). The mean score of the ten items is calculated and a higher score indicates more severe symptoms. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT04838860/registered