UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028804 |
|---|---|
| Receipt number | R000032960 |
| Scientific Title | An exploratory study analyzing the effect of abatacept therapy on serostatus in Japanese real world as well as the relationship between efficacy evaluation with clinical parameters and changes in serostatus |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2022/03/04 14:53:39 |
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Basic information
Public title
An exploratory study analyzing the effect of abatacept therapy on serostatus in Japanese real world as well as the relationship between efficacy evaluation with clinical parameters and changes in serostatus
Acronym
An exploratory study analyzing the effect of abatacept therapy on serostatus
Scientific Title
An exploratory study analyzing the effect of abatacept therapy on serostatus in Japanese real world as well as the relationship between efficacy evaluation with clinical parameters and changes in serostatus
Scientific Title:Acronym
An exploratory study analyzing the effect of abatacept therapy on serostatus
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We planned an exploratory study, in which retrospectively analyzing the effect of abatacept therapy on serostatus in Japanese real world as well as the relationship between efficacy evaluation with clinical parameters and changes in serostatus using the preceding cohort study(Kyushu multicenter rheumatoid arthritis ultrasound prospective cohort study).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The seroconversion rate of IgM-ACPA at 12 months after treatment
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
RA patients who meet 2010 ACR/EULAR Classification Criteria for RA
Patients who consulted at Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences and research cooperation institutions between June 2013 and June 2017
>Abatacept arm
Patients who meet Japan College of Rheumatology guidelines for the use of abatacept against RA and started abatacept treatment
Patients who were able to be follow-upped for 12 months after introduction of the therapy
Patients who had no history of biological agents
>MTX arm (Control arm)
Patients who were able to be follow-upped for 12 months after introduction of the therapy
Patients who were matched with age and disease duration with abatacept arm
Key exclusion criteria
Patients who are judges as inappropriate for enrollment to the study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawakami |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Immunology and Rheumatology
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7260
atsushik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shin-ya |
| Middle name | |
| Last name | Kawashiri |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Community Medicine
Zip code
8528501
Address
1-12-4 Sakamoto, Nagasaki 852-8523, Japan
TEL
095-819-7189
Homepage URL
shin-ya@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb K.K.
ONO 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
Nagasaki University Hospital
Address
Sakamoto 1-7-1, Nagasaki
Tel
095-819-7726
none
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
| 2017 | Year | 09 | Month | 01 | 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
| 2017 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Observation for 12 months after initiation of treatment
Management information
Registered date
| 2017 | Year | 08 | Month | 24 | Day |
Last modified on
| 2022 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032960
