UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023071 |
|---|---|
| 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 |
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Basic information
Public title
Actemra All-Patient, Long-Term Special Drug Use Surveillance
Acronym
Actemra All-Patient, Long-Term Special Drug Use Surveillance
Scientific Title
Actemra All-Patient, Long-Term Special Drug Use Surveillance
Scientific Title:Acronym
Actemra All-Patient, Long-Term Special Drug Use Surveillance
Region
| Japan |
Condition
Condition
Castleman's disease
Classification by specialty
| Hematology and clinical oncology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All Patients with CD without an indication for lymphadenectomy who have symptoms and laboratory findings for which tocilizumab were administrated.
Key exclusion criteria
No criteria
Target sample size
99999999999
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Joji Mochizuki |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Pharmacovigilance Dept.
Zip code
Address
1-1 Muromachi 2-Chome, Chuo-ku Tokyo, JAPAN
TEL
03-3273-0905
mochizukijuj@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Nomura |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Pharmacovigilance Dept.
Zip code
Address
1-1 Muromachi 2-Chome, Chuo-ku Tokyo, JAPAN
TEL
03-3273-0905
Homepage URL
nomuramkt@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 02 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 02 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 25 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 02 | Day |
Other
Other related information
Castleman's disease, adverse event, infection, CRP, fibrinogen, ESR, hemoglobin, albumin, PS, interstitial pneumonia, rash, hepatomegaly, splenomegaly, secondary amyloidosis, neurological symptoms
Management information
Registered date
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2017 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026578
