Unique ID issued by UMIN | UMIN000023071 |
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Receipt number | R000026578 |
Scientific Title | Actemra All-Patient, Long-Term Special Drug Use Surveillance |
Date of disclosure of the study information | 2016/07/08 |
Last modified on | 2017/03/13 11:57:57 |
Actemra All-Patient, Long-Term Special Drug Use Surveillance
Actemra All-Patient, Long-Term Special Drug Use Surveillance
Actemra All-Patient, Long-Term Special Drug Use Surveillance
Actemra All-Patient, Long-Term Special Drug Use Surveillance
Japan |
Castleman's disease
Hematology and clinical oncology | Clinical immunology |
Others
NO
The study is being conducted to evaluate and analyze the incidence of adverse drug reactions (ADRs) and factors influencing safety and efficacy during routine clinical practice (including long-term treatment) in patients with Castleman's disease receiving Actemra for Intravenous Infusion 80 mg, 200 mg, or 400 mg with the intention of including the data in the reexamination application.
Safety,Efficacy
Safety:
Adverse reaction incidence and infection
Efficacy:
Improvement in the clinical symptoms and laboratory findings of Castleman's disease
Symptoms and findings including CRP, fibrinogen, ESR, hemoglobin, albumin, and PS.
CRP, hemoglobin, PS are assessed biweekly for 3 years.
Fibrinogen, ESR, albumin are assessed once a 4 week for 3 years.
Safety:
-Incidence of ADRs and infections by patient baseline characteristics
-Incidence of ADRs and infections in special patient populations
-Incidence of serious adverse events
-Incidence of ADRs and infections during long-term treatment (>=12 months)
-Effects on infection
-Effects on cardiac function
Efficacy:
-Evaluation of enlarged lymph nodes
-Percent reduction in short axis x longest diameter of evaluable lesions (neck, chest, abdomen, pelvis, other site)
-Effect on clinical and associated symptoms of Castleman's disease
-Clinical symptoms, interstitial pneumonia, rash, hepatomegaly, splenomegaly, secondary amyloidosis, neurological symptoms
-Actemra treatment status
-Treatment status, reason for treatment discontinuation in patients with treatment discontinuation
-Detailed information on treatment discontinuations due to death must be recorded in the adverse events section.
-Time course of steroid dose
Observational
Not applicable |
Not applicable |
Male and Female
All Patients with CD without an indication for lymphadenectomy who have symptoms and laboratory findings for which tocilizumab were administrated.
No criteria
99999999999
1st name | |
Middle name | |
Last name | Joji Mochizuki |
Chugai Pharmaceutical Co. Ltd.
Pharmacovigilance Dept.
1-1 Muromachi 2-Chome, Chuo-ku Tokyo, JAPAN
03-3273-0905
mochizukijuj@chugai-pharm.co.jp
1st name | |
Middle name | |
Last name | Makoto Nomura |
Chugai Pharmaceutical Co. Ltd.
Pharmacovigilance Dept.
1-1 Muromachi 2-Chome, Chuo-ku Tokyo, JAPAN
03-3273-0905
nomuramkt@chugai-pharm.co.jp
Chugai Pharmaceutical Co. Ltd.
Chugai Pharmaceutical Co. Ltd.
Profit organization
NO
2016 | Year | 07 | Month | 08 | Day |
Unpublished
Completed
2005 | Year | 05 | Month | 13 | Day |
2005 | Year | 06 | Month | 13 | Day |
2014 | Year | 06 | Month | 02 | Day |
2014 | Year | 06 | Month | 02 | Day |
2016 | Year | 05 | Month | 25 | Day |
2016 | Year | 06 | Month | 02 | Day |
Castleman's disease, adverse event, infection, CRP, fibrinogen, ESR, hemoglobin, albumin, PS, interstitial pneumonia, rash, hepatomegaly, splenomegaly, secondary amyloidosis, neurological symptoms
2016 | Year | 07 | Month | 08 | Day |
2017 | Year | 03 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026578
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