臨床研究等提出・公開システム

Scientific Title	A prospective observational study to investigate real-world IMmunogenicity of theraPeutic Antibodies and to identify faCTors responsible for the interindividual variability (IMPACT study)
Public Title	A prospective observational study to investigate real-world IMmunogenicity of theraPeutic Antibodies and to identify faCTors responsible for the interindividual variability (IMPACT study)

Contact for Scientific Queries	Name	Fukudo Masahide
	Affiliation	Sapporo Medical University Hospital
	Address	South-1, West-16, Chuo-ku, Sapporo, Hokkaido
	Telephone	+81-11-688-9686
	E-mail	fukudom@sapmed.ac.jp
Contact for Public Queries	Name	Fukudo Masahide
	Affiliation	Sapporo Medical University Hospital
	Address	South-1, West-16, Chuo-ku, Sapporo, Hokkaido
	Telephone	+81-11-688-9686
	E-mail	fukudom@sapmed.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 29, 2022
Actual date of first enrollment
Target sample size		1000
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects whose medical care and prognostic information can be obtained from medical records
	Exclusion Criteria	Subjects presenting with any of the following will be excluded from the study: 1. Subjects who requested non-participation in this study based on a published opt-out document. 2. Subjects who are participating in or interested in participating in other clinical trials during the study period. 3. Subjects who are judged as not suitable for participating in this study by treating physician.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		IBD, Psoriasis, Palmoplantar pustulosis, Malignant tumors (Melanoma etc.), RA, Autoimmune diseases
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		D015212 , D011565, D008545, D001172, D001327, D009369
Intervention(s) Code
Primary Outcome(s)		The rate of anti-drug antibody (ADA) development
Secondary Outcome(s)		-The titer of ADA -The presence of neutralizing antibody (NAb) -The time to first development of ADA/NAb after start of treatment -Serum drug concentrations -Serum chemokine (CXCL12 etc.) protein levels -Duration of response -The incidence of infusion reactions -The incidence of genetic polymorphisms (CXCL12, FCGRT, HLA etc.)

Primary Sponsor	Sapporo Medical University Hospital

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Sapporo Medical University Hospital
Address	South-1, West-16, Chuo-ku, Sapporo 060-8543, Hokkaido
Telephone	+81-11-611-2111
E-Mail	ji-rskk@sapmed.ac.jp
Approval Status	Approval
Date of approval	Oct. 17, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history