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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO328MCD2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2009-012380-34 | EudraCT Number |
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The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.
This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double blind (neither investigator nor the participant knows the treatment that the participant receives), placebo controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), study to assess the efficacy and safety of CNTO 328 plus BSC compared with BSC in patients with symptomatic Multicentric Castleman's Disease. The study mainly consists of 3 phases, including: the screening phase (majority of assessments performed within 28 days of first dose), the treatment phase (blinded and unblinded), and the follow up phase. In the blinded treatment phase, approximately 78 patients will be randomly assigned in 1:2 ratios to either of 2 treatment groups, ie, Placebo + BSC, or CNTO 328 + BSC. Participants receiving placebo + BSC during blinded treatment period who do not respond and have treatment failure will have the option to crossover and receive siltuximab + BSC during unbllinded treatent period. The follow up phase will be 3 months after last dose of study medication and the survival will be followed up until the study ends. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, patient-recorded temperature, and physical examination will be monitored throughout the study. The total study duration will be 5 years after the last patient starts study medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Siltuximab+best supportive care (BSC) | Experimental | Siltuximab 11 mg/kg will be administered as a 1-hour intravenous infusion every 3 weeks + BSC. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siltuximab | Drug | Siltuximab 11 mg/kg will be administered by 1-hour intravenous infusion every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review | 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). | From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from study, or up to 48 weeks after last participant started study medication(approximately 3 years), whichever occurred earlier |
| Measure | Description | Time Frame |
|---|---|---|
| Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review | Duration of tumor and symptomatic response is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure. Whenever possible, treatment failure documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35793409 | Derived | van Rhee F, Rosenthal A, Kanhai K, Martin R, Nishimura K, Hoering A, Fajgenbaum DC. Siltuximab is associated with improved progression-free survival in idiopathic multicentric Castleman disease. Blood Adv. 2022 Aug 23;6(16):4773-4781. doi: 10.1182/bloodadvances.2022007112. | |
| 28087540 | Derived | Fajgenbaum DC, Uldrick TS, Bagg A, Frank D, Wu D, Srkalovic G, Simpson D, Liu AY, Menke D, Chandrakasan S, Lechowicz MJ, Wong RS, Pierson S, Paessler M, Rossi JF, Ide M, Ruth J, Croglio M, Suarez A, Krymskaya V, Chadburn A, Colleoni G, Nasta S, Jayanthan R, Nabel CS, Casper C, Dispenzieri A, Fossa A, Kelleher D, Kurzrock R, Voorhees P, Dogan A, Yoshizaki K, van Rhee F, Oksenhendler E, Jaffe ES, Elenitoba-Johnson KS, Lim MS. International, evidence-based consensus diagnostic criteria for HHV-8-negative/idiopathic multicentric Castleman disease. Blood. 2017 Mar 23;129(12):1646-1657. doi: 10.1182/blood-2016-10-746933. Epub 2017 Jan 13. |
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79 participants were enrolled, randomized and treated during the blinded treatment period. 53 received siltuximab+best supportive care (BSC) and 26 received placebo+BSC.13 participants who did not respond to placebo+BSC during the blinded treatment period, received siltuximab+BSC during the unblinded treatment period.
79 participants were enrolled at 38 study centers in 19 countries. The first participant signed the informed consent on 09 Feb 2010, and the last participant's last visit for the primary analysis was 28 Feb 2013. The data until the end of study is presented here.
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| ID | Title | Description |
|---|---|---|
| FG000 | Siltuximab + Best Supportive Care (BSC) | Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Blinded Treatment |
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| Placebo | Drug | Placebo will be administered by 1-hour intravenous infusion every 3 weeks |
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| 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. |
|
| From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment (approximately 3 years) |
| Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review | Overall tumor response is CR + PR assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC). | From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years) |
| Median Duration of Tumor Response - by Independent Radiology Review | Duration of tumor response is defined as time from first documentation of tumor response to tumor progression. Tumour response is complete response (CR) + partial response (PR) as assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC). | From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years) |
| Time to Treatment Failure | Time to treatment failure was defined as the time from randomization until the participant fails treatment. Treatment failure was defined as any of the following: a sustained increase from baseline in disease related symptoms >=Grade 2 persisting for at least 3 weeks despite best supportive care (BSC); onset of any new disease related Grade 3 or higher symptom despite BSC; sustained (ie, at least 3 weeks) deterioration in performance status (increase from baseline in Eastern Cooperative Oncology Group Performance Status by more than 1 point) despite BSC; radiologic progression, as measured by modified Cheson criteria; Initiation of any other therapy intended to treat multicentric Castleman's disease ie, prohibited treatments. Statistical analysis shows difference in treatment failure rate (siltuximab+BSC minus Placebo+BSC). | From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years), whichever occurred earlier |
| Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate) | Hemoglobin response rate is defined as percentage of participants who achieved >= 15 g/L hemoglobin at Week 13. | Week 13 |
| Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate) | Hemoglobin response rate is defined as percentage of participants who achieved >= 20 g/L hemoglobin at Week 13. | Week 13 |
| Percentage of Participants Who Discontinued Corticosteroids | Percentage of participants who discontinued corticosteroids during blinded treatment period and who were dependent on corticosteroids at baseline (Day 1 of Cycle 1). | From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment (approximately 3 years) |
| 6-year Survival Rate | Overall survival was defined as percent chance of survival of participants who were still alive at 6 years from time of first study treatment was analyzed. | until 6 years |
| Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman's Disease Symptom Scale (MCD-SS) Score From Baseline | A patient-reported symptom scale. Symptom presence/absence and severity are noted on an anchor-based numeric scale. Scores range from 1 (very mild) to 5 (very severe). | From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years) |
| Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline | The FACIT-F, a 13-item instrument, was designed to measure patient-reported fatigue. It is one of the suite of FACIT instruments developed for outcomes in cancer. Concepts measured in the scale include tiredness, weakness, and difficulty conducting usual functional activities or social interaction due to fatigue. Response options range from "not at all" (0) to "very much" (4), and yield a summary score. Total FACIT-F score is the sum of 13 items, ranging from 0 (not at all) to 52 (very much). Higher scores represent better outcomes. | From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years) |
| Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline | SF-36 is a questionnaire and PCS is a part of subscale assessing physical functioning, role-physical, bodily pain, and general health. The scores range from 0 (worst score) to 100 (best score), with a higher score indicating better quality of life. | From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years) |
| Los Angeles |
| California |
| United States |
| Tampa | Florida | United States |
| Boston | Massachusetts | United States |
| Lansing | Michigan | United States |
| Rochester | Minnesota | United States |
| Chapel Hill | North Carolina | United States |
| Greenville | South Carolina | United States |
| Houston | Texas | United States |
| Salt Lake City | Utah | United States |
| Seattle | Washington | United States |
| East Melbourne | Australia |
| Brussels | Belgium |
| Leuven | Belgium |
| BrasÃlia | Brazil |
| Porto Alegre | Brazil |
| Rio de Janeiro | Brazil |
| São Paulo | Brazil |
| Toronto | Canada |
| Beijing | China |
| Chengdu | China |
| Guangzhou | China |
| Hangzhou | China |
| Shanghai | China |
| Cairo | Egypt |
| Clermont-Ferrand | France |
| Grenoble | France |
| Lille | France |
| Montpellier | France |
| Paris | France |
| Rennes | France |
| Tours | France |
| Vandœuvre-lès-Nancy | France |
| Berlin | Germany |
| Mainz | Germany |
| München | Germany |
| Shatin | Hong Kong |
| Budapest | Hungary |
| Hyderabad | India |
| Pune | India |
| Petah Tikva | Israel |
| Ramat Gan | Israel |
| Pandan | Malaysia |
| Rotterdam | Netherlands |
| Auckland | New Zealand |
| Oslo | Norway |
| Kazan' | Russia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Singapore | Singapore |
| Seoul | South Korea |
| Barcelona | Spain |
| Madrid | Spain |
| Taipei | Taiwan |
| London | United Kingdom |
| Manchester | United Kingdom |
| 25042199 | Derived | van Rhee F, Wong RS, Munshi N, Rossi JF, Ke XY, Fossa A, Simpson D, Capra M, Liu T, Hsieh RK, Goh YT, Zhu J, Cho SG, Ren H, Cavet J, Bandekar R, Rothman M, Puchalski TA, Reddy M, van de Velde H, Vermeulen J, Casper C. Siltuximab for multicentric Castleman's disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014 Aug;15(9):966-74. doi: 10.1016/S1470-2045(14)70319-5. Epub 2014 Jul 17. |
| FG001 | Placebo + Best Supportive Care (BSC) | Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant's treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier. |
| COMPLETED |
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| NOT COMPLETED |
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| Unblinded Treatment |
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|
| Follow-Up Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Best Supportive Care (BSC) | Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant's treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier. |
| BG001 | Siltuximab + Best Supportive Care (BSC) | Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review | 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). | Intent-to-treat (ITT) population: all randomized participants. | Posted | Number | Percentage of participants | From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from study, or up to 48 weeks after last participant started study medication(approximately 3 years), whichever occurred earlier |
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| Secondary | Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review | Duration of tumor and symptomatic response is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure. Whenever possible, treatment failure documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions. 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. | All randomized participants who achieved durable tumor and symptomatic response during blinded treatment period as per independent review. | Posted | Median | Full Range | Days | From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment (approximately 3 years) |
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| Secondary | Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review | Overall tumor response is CR + PR assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC). | Response-evaluable Population: included participants who received at least 1 administration of siltuximab/placebo and had at least 1 post-baseline radiologic disease evaluation. | Posted | Number | Percentage of participants | From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years) |
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| Secondary | Median Duration of Tumor Response - by Independent Radiology Review | Duration of tumor response is defined as time from first documentation of tumor response to tumor progression. Tumour response is complete response (CR) + partial response (PR) as assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC). | All randomized participants who achieved tumor response during blinded treatment period as per independent review. | Posted | Median | Full Range | Days | From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years) |
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| Secondary | Time to Treatment Failure | Time to treatment failure was defined as the time from randomization until the participant fails treatment. Treatment failure was defined as any of the following: a sustained increase from baseline in disease related symptoms >=Grade 2 persisting for at least 3 weeks despite best supportive care (BSC); onset of any new disease related Grade 3 or higher symptom despite BSC; sustained (ie, at least 3 weeks) deterioration in performance status (increase from baseline in Eastern Cooperative Oncology Group Performance Status by more than 1 point) despite BSC; radiologic progression, as measured by modified Cheson criteria; Initiation of any other therapy intended to treat multicentric Castleman's disease ie, prohibited treatments. Statistical analysis shows difference in treatment failure rate (siltuximab+BSC minus Placebo+BSC). | Intent-to-treat (ITT) population: all randomized participants. | Posted | Median | 95% Confidence Interval | Days | From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years), whichever occurred earlier |
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| Secondary | Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate) | Hemoglobin response rate is defined as percentage of participants who achieved >= 15 g/L hemoglobin at Week 13. | Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 postbaseline hemoglobin evaluation. | Posted | Number | Percentage of participants | Week 13 |
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| Secondary | Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate) | Hemoglobin response rate is defined as percentage of participants who achieved >= 20 g/L hemoglobin at Week 13. | Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 post-baseline hemoglobin evaluation. | Posted | Number | Percentage of participants | Week 13 |
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| Secondary | Percentage of Participants Who Discontinued Corticosteroids | Percentage of participants who discontinued corticosteroids during blinded treatment period and who were dependent on corticosteroids at baseline (Day 1 of Cycle 1). | All randomized participants who were dependent on corticosteroids at baseline. | Posted | Number | Percentage of participants | From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment (approximately 3 years) |
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| Secondary | 6-year Survival Rate | Overall survival was defined as percent chance of survival of participants who were still alive at 6 years from time of first study treatment was analyzed. | Safety Analysis set included all randomized participants who received at least 1 dose of study agent. | Posted | Median | 95% Confidence Interval | Percent chance of survival | until 6 years |
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| Secondary | Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman's Disease Symptom Scale (MCD-SS) Score From Baseline | A patient-reported symptom scale. Symptom presence/absence and severity are noted on an anchor-based numeric scale. Scores range from 1 (very mild) to 5 (very severe). | Intent-to-treat (ITT) population: all randomized participants. | Posted | Median | Full Range | Days | From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years) |
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| Secondary | Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline | The FACIT-F, a 13-item instrument, was designed to measure patient-reported fatigue. It is one of the suite of FACIT instruments developed for outcomes in cancer. Concepts measured in the scale include tiredness, weakness, and difficulty conducting usual functional activities or social interaction due to fatigue. Response options range from "not at all" (0) to "very much" (4), and yield a summary score. Total FACIT-F score is the sum of 13 items, ranging from 0 (not at all) to 52 (very much). Higher scores represent better outcomes. | Intent-to-treat (ITT) population: all randomized participants. | Posted | Median | 95% Confidence Interval | Days | From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years) |
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| Secondary | Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline | SF-36 is a questionnaire and PCS is a part of subscale assessing physical functioning, role-physical, bodily pain, and general health. The scores range from 0 (worst score) to 100 (best score), with a higher score indicating better quality of life. | Intent-to-treat (ITT) population: all randomized participants. | Posted | Median | 95% Confidence Interval | Days | From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years) |
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Up to 7 years
Safety Analysis set included all participants who received at least 1 dose of study drug in blinded and unblinded treatment period until 48 weeks after the last subject started study treatment (approximately 3 years). Participants who continued in the study from Week 48 through the end-of-study (5 years after the last participant started study treatment) were included in the Follow-up analysis set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + Best Supportive Care (BSC) (Blinded) | Participants received placebo as a 1-hour intravenous infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last participant started study treatment, whichever occurred earlier. Participants who discontinued or completed treatment period up to Week 48, and who consented to enter the follow-up period were continued to be followed up during the course of follow-up period. | 7 | 26 | 25 | 26 | ||
| EG001 | Siltuximab + Best Supportive Care (BSC) (Blinded) | Participants received siltuximab 11mg/kg as a 1-hour intravenous infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason completed the end-of-treatment visit and entered the follow-up period. | 12 | 53 | 53 | 53 | ||
| EG002 | Siltuximab + Best Supportive Care (BSC) (Unblinded) | Participants who had documented treatment failure and wished to continue treatment, their treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab during the unblinded treatment period. | 4 | 13 | 13 | 13 | ||
| EG003 | Placebo + BSC (Follow-up Period) | No study treatment was administered during the follow-up period (up to 3 months after last study agent administration [placebo as a 1 hour IV infusion every 3 weeks along with BSC]) and participants were followed until death, lost to follow up, withdrawal of consent, death of 50 % of participants, or the end of the study, whichever occurred earlier. | 1 | 6 | 5 | 6 | ||
| EG004 | Siltuximab + BSC (Follow-up Period) | No study treatment was administered during the follow-up period (up to 3 months after last study agent administration [siltuximab 11mg/kg as a 1 hour IV infusion every 3 weeks along with ]) and participants were followed until death, lost to follow up, withdrawal of consent, death of 50 % of participants, or the end of the study, whichever occurred earlier. | 3 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Vitreous Haemorrhage | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Umbilical Hernia | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Cholecystitis Chronic | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Wound Secretion | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Mycobacterium Test | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Poems Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| T-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Renal Colic | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Ureteral Disorder | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pain Management | Surgical and medical procedures | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Noninfective Conjunctivitis | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Periorbital Oedema | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Tongue Ulceration | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Face Oedema | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Generalised Oedema | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Localised Oedema | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Rash Pustular | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blood Albumin Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Serum Ferritin Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Enzyme Abnormality | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Tumour Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oedema Genital | Reproductive system and breast disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Skin Induration | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Lymph Node Pain | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Monocytosis | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Idiopathic Orbital Inflammation | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Ileus Paralytic | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Tongue Coated | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Infusion Site Extravasation | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Herpes Virus Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Post-Traumatic Pain | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Procedural Nausea | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Wound Complication | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blood Folate Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blood Iron Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blood Phosphorus Increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Haemoglobin Increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Iron Binding Capacity Total Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Iron Binding Capacity Unsaturated Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Platelet Count Increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Protein Total Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Protein Total Increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Protein Urine Present | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Reticulocyte Count Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Reticulocyte Percentage Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Vitamin B12 Decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypocholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Scrotal Swelling | Reproductive system and breast disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Nasal Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DIRECTOR CLINICAL RESEARCH | Janssen R&D US | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| C537372 | Multi-centric Castleman's Disease |
| C537834 | Macular dystrophy, corneal type 1 |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C504234 | siltuximab |
Not provided
Not provided
Not provided
| Adverse Event |
|
| Male |
|
| BELGIUM |
|
| BRAZIL |
|
| CANADA |
|
| CHINA |
|
| EGYPT |
|
| FRANCE |
|
| GERMANY |
|
| HONG KONG |
|
| ISRAEL |
|
| NEW ZEALAND |
|
| NORWAY |
|
| RUSSIAN FEDERATION |
|
| SINGAPORE |
|
| SOUTH KOREA |
|
| SPAIN |
|
| TAIWAN |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms |
| Fisher Exact |
Without adjusting for the stratification factor: corticosteroid use |
| 0.0004 |
| difference in the response rate |
| 34.0 |
| 2-Sided |
| 95 |
| 11.1 |
| 54.8 |
| Superiority or Other |
| OG001 | Siltuximab + Best Supportive Care (BSC) | Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
|
|
| OG001 | Siltuximab + Best Supportive Care (BSC) | Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
|
|
|
| OG001 | Siltuximab + Best Supportive Care (BSC) | Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
|
|
| OG001 | Siltuximab + Best Supportive Care (BSC) | Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
|
|
|
| OG001 |
| Siltuximab + Best Supportive Care (BSC) |
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
|
|
|
| Siltuximab + Best Supportive Care (BSC) |
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
|
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Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
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Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
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| OG001 | Siltuximab + Best Supportive Care (BSC) | Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
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| Siltuximab + Best Supportive Care (BSC) |
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant's treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. |
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