UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011102 |
|---|---|
| Receipt number | R000013004 |
| Scientific Title | Actemra SC drug use results survey |
| Date of disclosure of the study information | 2013/07/04 |
| Last modified on | 2023/10/03 16:21:23 |
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Basic information
Public title
Actemra SC drug use results survey
Acronym
Actemra SC drug use results survey
Scientific Title
Actemra SC drug use results survey
Scientific Title:Acronym
Actemra SC drug use results survey
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Medicine in general | Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ascertain the safety and effectiveness of ACT-SC in post-marketing use for patients with rheumatoid arthritis (RA).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse reaction incidence
Changes in Disease Activity Score 28 (DAS28-ESR) and Clinical disease activity index (CDAI) at week 12, 26.
Key secondary outcomes
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
Patients who have no previous medical history of Actemra SC for RA.
Key exclusion criteria
No criteria
Target sample size
1000
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 Nihonbashi-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 Nihonbashi-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
| 2013 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
0
Results
Not applicable
Results date posted
| 2023 | Year | 10 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not applicable
Participant flow
Not applicable
Adverse events
Not applicable
Outcome measures
Not applicable
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 26 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 08 | Day |
Other
Other related information
Adverse events
Tender joint count, Swollen joint count, Patient global assessment on VAS, Physician global assessment on VAS, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)
Management information
Registered date
| 2013 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013004
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
