Osteoarthritis of knee and hip with history of administration of SI-613 / ONO-5704
Conditions
Interventions
Allergy test by blood sampling
-Basophil activation test:Blood sampling volume is about 10 mL
-An allergen-specific IgE test(ELISA):Blood sampling volume is about 15 mL
-An allergen-specific IgE test(
Sponsors
Hayama Koremasa
SEIKAGAKU CORPORATION
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.*1 2. Patients who fall under any of the following. a. Experienced anaphylaxis (including serious allergies). 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 symptoms in each organ such as the patient's skin/mucous membrane, digestive organs, respiratory organs, circulatory organs, and neurological symptoms. Patients could be enrolled who had experienced life-threatening symptoms or required emergency or hospitalization treatment, or whose symptoms were observed in multiple organs and one of them was more than moderate symptom indicated by the classification of severity based on clinical findings in the anaphylaxis guideline. 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 18 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. *1 :It does not matter whether JOYCLU intra-articular injection was administered at investigational site.
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of anaphylaxis (including serious allergies) within 4 weeks prior to informed consent. 2. Patients with a confirmed diagnosis of anaphylaxis to DF-Na, HA or Macrogol or a history of anaphylaxis of unknown cause before first injection of JOYCLU intra-articular injection. 3. Patients with uncontrollable asthma (Patients at high risk of test-induced serious seizures). 4. Patients with significant cardiovascular disease such as coronary artery disease or lethal arrhythmia (Patients who have a safety concern with anaphylactic treatments such as adrenaline). 5. Patients who do not give voluntary written informed consent to participate in the study. 6. Patients who are considered ineligible by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive rate for each test reagent in prick test | — |
Secondary
| Measure | Time frame |
|---|---|
| -Positive rate for each test reagent in Basophil Activation Test -Absorbance for each test reagent in an allergen-specific IgE test (ELISA) -Positive rate for each test reagent in an allergen-specific IgE test (Test kit) -Retention rate for specific alleles in genome-wide association study by genetic polymorphisms measured by genotyping -Rate of study subjects with an increase of each protein which obtained by the test result of the search of molecules secreted during basophil activation -Concentration of non-proteins(histamine,cysteinyl leukotrienes and platelet activating factor(PAF)) in culture supernatants in the search of molecules secreted during basophil activation | — |
Contacts
Public ContactKoremasa Hayama
Nihon University Itabashi Hospital
Outcome results
None listed