EUCTR2010-022837-27-DE
Active, not recruiting
Phase 1
An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Subjects with Multicentric Castleman's Disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multicentric Castleman's Disease
- Sponsor
- Janssen-Cilag International N.V.
- Enrollment
- 75
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Have 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 59
- •F.1\.3 Elderly (\>\=65 years) yes
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, or intolerance to monoclonal antibodies or to murine, chimeric, or human proteins or their excipients
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's DiseaseMulticentric Castleman's DiseaseMedDRA version: 14.1 Level: PT Classification code 10050251 Term: Castleman's disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2010-022837-27-GBJanssen-Cilag International N.V.60
Active, not recruiting
Phase 1
A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's DiseaseEUCTR2010-022837-27-BEJanssen-Cilag International N.V.75
Active, not recruiting
Phase 1
A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's DiseaseEUCTR2010-022837-27-ESJanssen-Cilag International N.V.80
Active, not recruiting
Phase 1
A Study to Evaluate the Safety and Effectiveness of Intravenous CR845 in Hemodialysis Patients with Moderate-to-Severe PruritusEUCTR2018-004572-35-CZCara Therapeutics, Inc.400
Active, not recruiting
Phase 1
A Study to Evaluate the Safety and Effectiveness of Intravenous CR845 in Hemodialysis Patients with Moderate-to-Severe PruritusModerate-to-Severe Pruritus in Hemodialysis PatientsTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2018-004572-35-PLCara Therapeutics INC400