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

JRCT ID: jRCT1040220009

Registered date:23/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Osteoarthritis of knee and hip with history of administration of SI-613 / ONO-5704
• Date of first enrollment: 28/04/2022
• Target sample size: 40
• Study type: Observational

Outcome(s)

Primary Outcome

-Basophil Activation Test
-An allergen-specific IgE test (ELISA)
-An allergen-specific IgE test (Test kit)
-Genome-wide association study by genotyping

• Secondary Outcome: None

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nishida Yoshihiro
• Secondary Sponsor: SEIKAGAKU CORPORATION