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

Clinical study on allergic factors in patients with osteoarthritis of the knee and hips who have been treated with SI-613/ONO-5704 - CONCEPTION

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1040220009
Enrollment
40
Registered
2022-04-23
Start date
2022-04-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

Nishida Yoshihiro
Lead Sponsor
SEIKAGAKU CORPORATION
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

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

Contacts

Public ContactYoshihiro Nishida

Nagoya University Hospital

ynishida@med.nagoya-u.ac.jp+81-52-741-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026