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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023071
Receipt No. 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

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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
Email 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
Email nomuramkt@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co. Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026578

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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