UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quantitative analysis of onset timing of interstitial lung disease during treatment with biologics
Title of the study (Brief title)	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	Hisashi Urushihara
Organization	Keio University
Division name	Drug Development and Regulatory Science, Faculty of Pharmacy
Address	1-5-30, Shiba-Koen, Minato-Ku, Tokyo
TEL	03-5400-2649
Email	urushihara-hs@pha.keio.ac.jp

Public contact
Name of contact person	Hisashi Urushihara
Organization	Keio University
Division name	Drug Development and Regulatory Science, Faculty of Pharmacy
Address	1-5-30, Shiba-Koen, Minato-Ku, Tokyo
TEL	03-5400-2649
Homepage URL
Email	urushihara-hs@pha.keio.ac.jp

Sponsor
Institute	Drug Development and Regulatory Science, Faculty of Pharmacy Keio University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017865