REMIT study

JRCT ID: jRCT1030240168

Registered date:18/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Allergic rhinitis
• Date of first enrollment: 18/06/2024
• Study type: Observational

Outcome(s)

Primary Outcome

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

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

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: <= 74age old
• Gender: Both

Include 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.

• Exclude 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)

Related Information

• Primary Sponsor: Doi Ohashi Katsuyo