UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016412 |
|---|---|
| Receipt number | R000019059 |
| Scientific Title | Risk of Hospitalized Bacterial Infections associated with Biologics Treatmentfor Rheumatoid Arthritis Patients: A real registry study. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2017/06/09 13:02:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Risk of Hospitalized Bacterial Infections associated with Biologics Treatmentfor Rheumatoid Arthritis Patients: A real registry study.
Acronym
Safety of biologics treatment for rheumatoid arthritis patients
Scientific Title
Risk of Hospitalized Bacterial Infections associated with Biologics Treatmentfor Rheumatoid Arthritis Patients: A real registry study.
Scientific Title:Acronym
Safety of biologics treatment for rheumatoid arthritis patients
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the risk of hspitalized bacterial infections associated with biologics treatment for rheumatoid arthritis patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hosiptalized bacterial ingections
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Rheumatoid arthritis patients who first treated with biologics between 2009 Jan 1 and 2014 Dec 31.
Key exclusion criteria
None
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Mori |
Organization
National Hospital Organization, Kumamoto Saishunsou National Hospital
Division name
Center for Rheumatic Disease
Zip code
Address
2659 Suya Kohshi, Kumamoto, Japan
TEL
81-96-242-1000
moris@saisyunsou1.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Mori |
Organization
National Hospital Organization, Kumamoto Saishunsou National Hospital
Division name
Center for Rheumatic Disease
Zip code
Address
2659 Suya Kohshi, Kumamoto, Japan
TEL
81-96-242-1000
Homepage URL
moris@saisyunsou1.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization, Kumamoto Saishunsou National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization, Kumamoto Saishunsou National Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
佐世保中央病院、NHO九州医療センター、NHO福岡病院、市民の森病院、吉玉クリニック、大分赤十字病院、横浜南共済病院、諫早総合病院、長崎大学公衆衛生学教室、埼玉医科大学国際尾量センター、近畿中央病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 01 | Day |
Other
Other related information
Analysis: Cox hazard analysis
Risk factor
Age, Sex, RA class & stage, smoking history, cormobideity (NIDDM, chronic renal disease), Chest CT findings(pulmonary emphysema or
interstitial pneumonia or airway disease), concurrent PSL, concurrent MTX
Management information
Registered date
| 2015 | Year | 02 | Month | 02 | Day |
Last modified on
| 2017 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019059
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
