UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015358 |
|---|---|
| Receipt number | R000017865 |
| Scientific Title | Quantitative analysis of onset timing of interstitial lung disease during treatment with biologics |
| Date of disclosure of the study information | 2014/10/09 |
| Last modified on | 2017/04/20 14:13:25 |
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Basic information
Public title
Quantitative analysis of onset timing of interstitial lung disease during treatment with biologics
Acronym
Onset timing of biologics-related interstitial lung disease
Scientific Title
Quantitative analysis of onset timing of interstitial lung disease during treatment with biologics
Scientific Title:Acronym
Onset timing of biologics-related interstitial lung disease
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantitative analysis and modeling of onset timing of interstitial lung disease associated with use of biologics with indication of rheumatoid arthritis, using Japanese hospital database including administrative and laboratory data
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Onset timing of interstitial lung disease
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Having ICD-10 codes (M05 & M06) for rheumatoid arthritis.
2. Treated with the following biologics; infliximab, tocilizumab, certolizumab pegol, adalimumab, golimumab, etanercept, and abatacept.
3. Having diagnoics codes for interstitial lung diseases after initiation of treatment with the above biologics.
Key exclusion criteria
1. Having diagnostic codes for interstitial lung diseases within 3 days after the treatment initiation.
2. Using anticancer drugs.
3. Under 18-years of age.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Urushihara |
Organization
Keio University
Division name
Drug Development and Regulatory Science, Faculty of Pharmacy
Zip code
Address
1-5-30, Shiba-Koen, Minato-Ku, Tokyo
TEL
03-5400-2649
urushihara-hs@pha.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Urushihara |
Organization
Keio University
Division name
Drug Development and Regulatory Science, Faculty of Pharmacy
Zip code
Address
1-5-30, Shiba-Koen, Minato-Ku, Tokyo
TEL
03-5400-2649
Homepage URL
urushihara-hs@pha.keio.ac.jp
Sponsor or person
Institute
Drug Development and Regulatory Science, Faculty of Pharmacy
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
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
| 2014 | Year | 10 | Month | 09 | 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
| 2014 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective analysis of large scale hospital database.
Management information
Registered date
| 2014 | Year | 10 | Month | 07 | Day |
Last modified on
| 2017 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017865
