UMIN-CTR Clinical Trial

Basic information
Public title	Nintedanib treatment for the patients with systemic scleroderma-associated interstitial lung disease-a prospective observational study
Acronym	Nintedanib for the patients with SSc-ILD
Scientific Title	Nintedanib treatment for the patients with systemic scleroderma-associated interstitial lung disease-a prospective observational study
Scientific Title:Acronym	Nintedanib for the patients with SSc-ILD
Region	Japan

Condition
Condition	Systemic scleroderma-associated interstitial lung disease
Classification by specialty	Hepato-biliary-pancreatic medicine Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and the efficacy of nintedanib for the patients with systemic scleroderma
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decline of forced vital capacity after 48 weeks
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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	(1) A Patient who was clinically diagnosed with SSc (2) A Patient who was clinically diagnosed with SSc-ILD (3) A Patient who will receive nintedanib within 1 month (4) Aged >=20 years and <85 years (5) A patient who agree that they participate by written consent
Key exclusion criteria	(1) Difficulty obtaining patients' consent (2) Severe heart disease (3) AST >=2*ULN, ALT >=2*ULN, or T-bil >=2*ULN (4) Pregnancy (5) Complication with other CTD, RA, SLE,PM/DM, MCTD, SjS, Behcet's disease, and vasculitis (6) Coexistence with pulmonary arterial hypertension, bronchial asthma, Malignant tumor, sarcoidosis, bronchiectasis, respiratory infection (7) A patient who already receive nintedanib or other anti-fibrotic agents (8) A patient with risk of fatal bleeding (9) Past history of thrombosis less than 3 months (10) A patient who started clinical trials less than 3 months (11) A patient improper to this clinical trial according to the decision of a principal investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Motoyasu Middle name Last name Kato
Organization	Juntendo University Hospital
Division name	Department of Respiratory Medicine
Zip code	1138431
Address	3-1-3, Hongo, Bunkyo-ku
TEL	0338133111
Email	mtkatou@juntendo.ac.jp

Public contact
Name of contact person	1st name Motoyasu Middle name Last name Kato
Organization	Juntendo University Hospital
Division name	Department of Respiratory Medicine
Zip code	1138431
Address	3-1-3, Hongo, Bunkyo-ku
TEL	0338133111
Homepage URL
Email	mtkatou@juntendo.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Juntendo University Hospital
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, Juntendo University Hospital
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	Juntendo Clinical Research and Trial Center
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel	0338133111
Email	kenkyu5858@juntendo.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	2020 Year 02 Month 27 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	Open public recruiting
Date of protocol fixation	2020 Year 02 Month 21 Day
Date of IRB	2020 Year 02 Month 21 Day
Anticipated trial start date	2020 Year 02 Month 21 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation study

Management information
Registered date	2020 Year 02 Month 26 Day
Last modified on	2020 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045166