UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037851 |
|---|---|
| Receipt number | R000043156 |
| Scientific Title | Incidence of Hospitalized Infection in Elderly Patients with Rheumatoid Arthritis on bDMARDs and tsDMARDs: A Healthcare Data-Based Cohort Study |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2023/05/30 11:40:38 |
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Basic information
Public title
Incidence of Hospitalized Infection in Elderly Patients with Rheumatoid Arthritis on bDMARDs and tsDMARDs: A Healthcare Data-Based Cohort Study
Acronym
Incidence of Hospitalized Infection in Elderly Patients with Rheumatoid Arthritis on bDMARDs and tsDMARDs: A Healthcare Data-Based Cohort Study
Scientific Title
Incidence of Hospitalized Infection in Elderly Patients with Rheumatoid Arthritis on bDMARDs and tsDMARDs: A Healthcare Data-Based Cohort Study
Scientific Title:Acronym
Incidence of Hospitalized Infection in Elderly Patients with Rheumatoid Arthritis on bDMARDs and tsDMARDs: A Healthcare Data-Based Cohort Study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey of hospitalized infection during bDMARDs and tsDMARDs users in elderly patients with rheumatoid arthritis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of infections requiring first hospitalized infection, morbidity (person-years), crude morbidity, crude hazard ratio of each bDMARDs and tsDMARDs to tocilizumab, adjusted hazard ratio, in elderly RA patients aged 75 years and older
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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 with RA who started new bDMARDs and tsDMARDs after 2014
Key exclusion criteria
1. Patients in hospital at baseline
2. Patients with other diseases indicated for the study therapy (behcet's disease, psoriasis, ankylosing spondylitis, kawasaki disease, crohn's disease, ulcerative colitis, juvenile idiopathic arthritis/adult still's disease, suppurative hidradenitis, castleman's disease, giant cell arteritis, takayasu's arteritis) at least once in the previous year
Target sample size
14000
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ouchi |
Organization
CHUGAI PHARMACEUTICAL CO.,LTD.
Division name
Medical Affairs Div.
Zip code
103-8324
Address
1-1 NIHONBASHI-MUROMACHI 2-CHOME,CHUO-KU TOKYO
TEL
03-3273-0866
ohuchikor@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kondo |
Organization
CHUGAI PHARMACEUTICAL CO.,LTD.
Division name
MEDICAL SCIENCE DEPT
Zip code
103-8324
Address
1-1 NIHONBASHI-MUROMACHI 2-CHOME,CHUO-KU TOKYO
TEL
03-3273-0866
Homepage URL
kondosts@chugai-pharm.co.jp
Sponsor or person
Institute
CHUGAI PHARMACEUTICAL CO.,LTD.
MEDICAL SCIENCE DEPT
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, DOGENZAKA, SHIBUYA, TOKYO
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2019 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
-
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/mr/advance-article/doi/10.1093/mr/road031/7113718
Number of participants that the trial has enrolled
5506
Results
Crude incidence rates (/100 person-years) of HIs were 3.99, 7.27, and 10.77, respectively. In the oldest group, aRRs (95% confidence interval) for HIs (b/tsDMARDs versus TCZ) were as follows: etanercept, 2.40 (1.24-4.61), adalimumab, 1.90 (0.75-4.83), golimumab, 1.21 (0.66-2.23), and abatacept, 0.89 (0.49-1.62). In the other age groups, the noticeable difference was a lower aRR of etanercept versus TCZ in the youngest group (0.30, 0.11-0.85).
Results date posted
| 2023 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 17 | Day |
Baseline Characteristics
We classified the patients into one of the three age groups by using their age at the first date of prescription of b/tsDMARDs as follows: aged <65 years, aged 65-74 years, and aged >75 years. The eligible population consisted of patients with RA who started treatment with a b/tsDMARD after 10 October 2014 when the previous guidelines for the management of RA in Japan were published . The study period was from 10 October 2013 (because we collected the baseline data for 12 months before the first prescription of a b/tsDMARD; see later) to the date of data extraction from the MDV database (28 February 2019) (Supplementary Figure S1). We focused on the period after the publication of the guidelines because we wanted to assess the incidence of HIs associated with b/tsDMARDs during the period when the treatment strategy for RA was expanded and to compare risks between b/tsDMARDs under the same (guideline-based) treatment conditions. Seven bDMARDs (tocilizumab, infliximab, etanercept, adalimumab, golimumab, certolizumab pegol and abatacept) and the first tsDMARD, tofacitinib, were available for use in Japan by the end of 2013. We included patients who were treated with a first b/tsDMARD after the diagnosis of RA because patients receiving a second or later b/tsDMARD may have had different clinical backgrounds, which would have made the comparison across b/tsDMARDs more difficult.
Participant flow
Of 302,591 patients with at least one RA diagnosis in the period from 1 April 2008 to 28 February 2019, 5506 eligible patients were identified (Figure 1). Among them, 76.4% were female and 58.9% were aged >65 years. At the index date, the treatment was initiated with TCZ(n=995 patients), etanercept(n=922), golimumab(n=1179), and abatacept(n=1227) more often than with the other b/tsDMARDs. The reasons for loss to follow-up were the end of the observation period (53.1%), the end of exposure (32.2%), the start of other b/tsDMARDs (12.8%), and the end of the study period (1.8%)
Adverse events
-
Outcome measures
The primary endpoint was the incidence of HIs in patients aged >75 years with RA who were treated with b/tsDMARDs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 28 | Day |
Other
Other related information
[Organization for analysis]
Medilead, Inc.
Address: 20-2 NISHI-SHINJUKU 3-CHOME, SHINJUKU-KU, TOKYO
Phone :03-6859-2295
[Organization providing data]
Medical Data Vision Co.,Ltd.
Address: 7 KANDAMITOSHIROCHO, CHIYODA-KU, TOKYO
Phone :03-5280-9571
[Study advisor]
Masayoshi Harigai, Department of Rheumatology, Tokyo Women's Medical University
Takao Fujii, Department of Rheumatology and Clinical Immunology, Wakayama Medical University
Yutaka Kawahito, Department of Inflammation and Immunology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
[Supervisor for statistical analysis]
Ataru Igarashi, Unit of Public Health and Preventive Medicine School of Medicine, Yokohama City University
Management information
Registered date
| 2019 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043156
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