臨床研究等提出・公開システム

Date of registration	June. 18, 2024
Last modified on	Dec. 03, 2025
Trial ID	jRCT1030240168

Scientific Title	Real world Evidence of effectiveness of house dust Mite sublingual Immunotherapy Tablets treatment in patients with allergic rhinitis
Public Title	REMIT study

Contact for Scientific Queries	Name	Doi Ohashi Katsuyo
	Affiliation	Torii Pharmaceutical Co., Ltd.
	Address	3-4-1 Nihonbashi Honcho, Chuo-ku, Tokyo
	Telephone	+81-3-3231-6811
	E-mail	katsuyo.doi@torii.co.jp
Contact for Public Queries	Name	Matsuhara Hiroki
	Affiliation	Torii Pharmaceutical Co., Ltd.
	Address	3-4-1 Nihonbashi Honcho, Chuo-ku, Tokyo
	Telephone	+81-3-3231-6811
	E-mail	ma_jrct@torii.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 18, 2024
Actual date of first enrollment		June. 20, 2024
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1. At least two 6-SQ HDM SLIT-tablets (10,000 JAU) prescriptions during the first FU year 2. Continuous enrollment (no gaps in insurance time-defined by days) for 12 months before the index event (in the pre-index period) 3. Continuous enrollment (no gaps in insurance time-defined by days) for at least 12 months after the index event (in the post-index period) For the control cohort, the same inclusion criteria will apply, with the exception of inclusion criterion 1.
	Exclusion Criteria	Other AIT without JCP SLIT tablets/drops prescription and prescriptions of any biologics 12 months before the index event (in the pre-index period)
	Age Minimum	0age over
	Age Maximum	74age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Allergic rhinitis
Primary Outcome(s)		Number of patients with at least one symptom-relieving AR prescriptions by each FU year Number of total symptom-relieving AR prescriptions by each FU year Change in total number of symptom-relieving AR prescriptions from the pre-index year (baseline) to each FU year
Secondary Outcome(s)		1.Number of symptom-relieving AR prescriptions per drug class by each FU year and change in total number of symptom-relieving AR prescriptions per drug class from the pre-index year (baseline) to each FU year 2.Healthcare resource utilization (HRU) 3.Anaphylaxis shock within 7 days related to 2 and 6-SQ HDM SLIT-tablets initiation: -Number of patients with anaphylaxis shock -Number of events of anaphylaxis shock 4.Number of patients with allergy-related comorbidities and number of comorbidities 5.Medical costs

Primary Sponsor	Torii Pharmaceutical Co., Ltd.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Non-Profit Organization MINS Research Ethics Co mmittee
Address	5-20-9-401 Mita, Minato-ku, Tokyo, Tokyo
Telephone	+81-3-6416-1868
E-Mail	npo-mins@j-irb.com
Approval Status	Approval
Date of approval	June. 06, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Dec. 03, 2025	(this page)	Changes
1	June. 18, 2024	Detail

List of change history