Clinical study on allergic factors of SI-613/ONO-5704

Not Applicable

• Conditions: Osteoarthritis of knee and hip with history of administration of SI-613 / ONO-5704

• Registration Number: JPRN-jRCT1040220009
• Lead Sponsor: ishida Yoshihiro

Brief Summary

In BAT, reagents containing DEH showed a significant association between positive/negative and Case/Control, suggesting that the characteristics of DEH may be involved in the anaphylactic symptoms after SI-613/ONO-5704 injection. In addition, DF IgE were detected in four (positive in BAT) of the 13 Cases by specific IgE antibody test (ELISA), suggesting the possibility that DF IgE is involved in the onset of anaphylaxis after injection.BAT and ELISA were found to be useful for investigating causal factors.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-23
• Study Completion: 2022-10-31
• Results First Posted: 2023-07-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1.Patients with osteoarthritis of the knee or hip who have received one or more JOYCLU intra-articular injection.
2. Patients who fall under any of the following.
a. Experienced anaphylaxis (including allergy).
Patients who have a history of anaphylactic (including serious allergies) symptoms that are considered to be associated with JOYCLU intra-articular injection after administration of JOYCLU intra-articular injection. Anaphylaxis (including serious allergies) was judged by a physician who performed the medical treatment based on the presence or absence of systemic symptoms such as the patient's skin, digestive organs, respiratory organs, circulatory organs, and neurological symptoms, or the need for urgent treatment and hospitalization.
b. No experiences of allergic symptoms.
Patients who do not have a history of allergic symptoms that are considered to be related to JOYCLU intra-articular injection after receiving JOYCLU intra-articular injection.
3. Male or female aged 20 years or older at the time of signing the informed consent.
4. Patients who give voluntary written informed consent to participate in the study after receiving and understanding the adequate explanation about the study.

Exclusion Criteria

1. Patients who have a history of anaphylaxis (including serious allergies) within 2 weeks prior to informed consent.
2. Patients who are considered ineligible by the principal investigator or sub-investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Basophil Activation Test<br>-An allergen-specific IgE test (ELISA)<br>-An allergen-specific IgE test (Test kit)<br>-Genome-wide association study by genotyping