UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021263 |
|---|---|
| Receipt number | R000023764 |
| Scientific Title | Long-Term Outocomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2023/02/02 08:38:02 |
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Basic information
Public title
Long-Term Outocomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
Acronym
Orencia Registry in Geographically Assembled Multicenter Investigation Study
Scientific Title
Long-Term Outocomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
Scientific Title:Acronym
Orencia Registry in Geographically Assembled Multicenter Investigation Study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the simplified disease activity index (SDAI) remission rate at 52 weeks of abatacept treatment initiated in routine clinical practice in Japan for patients with rheumatoid arthritis (RA) who have inadequate response to at least 1 conventional synthetic disease modifying antirheumatic drug (csDMARD) and are treatment-naive to biologic agents (biologic-naive)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
percentage of achievement in SDAI remission after administration of
abatacept for 52 weeks
Key secondary outcomes
1) Percentage of achievement in low disease activity by SDAI after 52 weeks
2) The following items during the observation period
a) Change in the percentage of disease activity category by SDAI, CDAI, DAS28-ESR and DAS28-CRP;
b) Change in SDAI, CDAI, DAS28-ESR, and DAS28-CRP
c) Treatment-responsive evaluation by DAS28-ESR, and DAS28-CRP
d) Change in J-HAQ score from the baseline and remission rate
e) Change in EQ-5D, pain VAS, and general VAS
f) Treatment continuation rate and the reason(s) for treatment discontinuation;
g) Survival rate
h) Serious Adverse Event
i) Rate of hospitalization
j) Rate of operation caused by rheumatoid arthritis
k) Change of ACPA and RF
l) Change in PRO parameters
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all the following criteria (items 1-7) are to be included as patients for this study.
1) Patients with RA who meet the 2010 American College of Rheumatology / European League against Rheumatisms (ACR/EULAR) RA Classification Criteria
2) Patients with RA with a moderate disease activity (SDAI: >11 and <=26)
3) Biologic-naive patients with treatment history >= 1 csDMARDs
4) Patients who meet the following criteria by hematological examination:
a) Peripheral white blood cell count: >=4,000/mm3
b) Peripheral lymphocyte count: >=1,000/mm3
c) Blood beta-D-glucan negative
5) Patients >= 20 years of age
6) Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study
Key exclusion criteria
Patients will be excluded from the study if have
1) Past history of hypersensitivity to the components of the abatacept preparation
2) Complication of a malignant tumor
3) Active infectious disease
4) Hepatitis B and hepatitis B virus carrier (HBs antigen positive)
5) Pregnancy or lactating, or with the possibility of the pregnancy or lactating
6)Been judged by the investigator or the co-investigator as being inappropriate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Harigai |
Organization
Tokyo Women's Medical University
Institute of Rheumatology
Division name
Department of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases
Zip code
162-0054
Address
10-22 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-5269-1711
Harigai.masayoshi@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroichi |
| Middle name | |
| Last name | Yamamoto |
Organization
Mebix, Inc.
Division name
Research promotion division
Zip code
107-0052
Address
1-11-44 Akasaka,Minato-ku,Tokyo
TEL
03-4362-4504
Homepage URL
hiroichi.yamamoto@mebix.co.jp
Sponsor or person
Institute
Bristol-Myers Squibb K.K.
Ono Pharmaceutical CO.,LTD.
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University Hospital Ethics Committee
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8112
krinri.bm@twmu.ac.jp
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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34915575/
Number of participants that the trial has enrolled
325
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
Main results already published
Date of protocol fixation
| 2015 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a non-interventional, prospective, multicenter study enrolling 300 patients in Japan consisting of patients diagnosed with moderate active RA, with inadequate response to csDMARD, who are biologic-naive and have initiated treatment in an ordinal medication in Japan with subcutaneous (SC)abatacept (subcutaneous injection, 125 mg/mL).
The study will start in November 2015 and end in October 2023.
The initiation of treatment with SC abatacept is a therapeutic decision by the physician which occurs before patient enrolment in the study. After enrollment, clinical assessments will be performed according to routine local clinical practice.
Management information
Registered date
| 2016 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023764
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| Registered date | File name |
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