JPRN-jRCTs031220327CompletedUnknown
Clinical study on the allergic symptoms experienced after injection of SI-613/ONO-5704 in patients with osteoarthritis of the knee and hip - ALLSEED
Hayama Koremasa0 sites40 target enrollmentStarted: September 9, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
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
- •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.
Investigators
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