NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031220327

Registered date:09/09/2022

Clinical study on the allergic symptoms experienced after injection of SI-613/ONO-5704

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedOsteoarthritis of knee and hip with history of administration of SI-613 / ONO-5704
Date of first enrollment30/09/2022
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)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(Test kit):Blood sampling volume is about 2 mL -Search for molecules secreted during basophil activation:Use the blood sample collected for basophil activation test Prick test One drop of each following test reagent is placed on a different spot on study subject's skin of the flexion side of the forearm, and administered intradermally by gently pricking over the test reagents with a prick test needle. -JOYCLU intra-articular injection(10-fold dilution) -JOYCLU intra-articular injection -Diclofenac etalhyaluronate sodium solution(10-fold dilution) -Diclofenac etalhyaluronate sodium solution -Diclofenac etalhyaluronate sodium solution(Contains 3 times the amount of Diclofenac etalhyaluronate sodium) -Macrogol 400 solution(10-fold dilution) -Macrogol 400 solution -Histamine dihydrochloride -Sterilized saline

Outcome(s)

Primary OutcomePositive rate for each test reagent in prick test
Secondary Outcome-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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1.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.
Exclude criteria1. 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.

Related Information

Contact

Public contact
Name Koremasa Hayama
Address 30-1 Oyaguchikami-cho,Itabashi-ku,Tokyo,JAPAN Tokyo Japan 173-8610
Telephone +81-3-3972-8111
E-mail hayama.koremasa@nihon-u.ac.jp
Affiliation Nihon University Itabashi Hospital
Scientific contact
Name Koremasa Hayama
Address 30-1 Oyaguchikami-cho,Itabashi-ku,Tokyo,JAPAN Tokyo Japan 173-8610
Telephone +81-3-3972-8111
E-mail hayama.koremasa@nihon-u.ac.jp
Affiliation Nihon University Itabashi Hospital