Actively Recruiting
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2024-09-23
221
Participants Needed
10
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, randomized Phase II/III clinical study to evaluate the efficacy and safety of GenaKumab in the treatment of active systemic juvenile idiopathic arthritis.
CONDITIONS
Official Title
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 2 years or older and younger than 18 years
- Confirmed diagnosis of systemic juvenile idiopathic arthritis according to 2001 ILAR criteria with onset before age 16 and symptoms for 2 or more months
- Symptoms include at least one arthritis case with recurrent fever lasting at least 3 consecutive days and at least one additional symptom such as rash, lymph node enlargement, liver/spleen swelling, or serositis
- Agreement to use effective contraception during the study and for 6 months after treatment ends
You will not qualify if you...
- Pregnant or breastfeeding females
- History of allergic reactions to investigational drugs or similar molecules, or inability to receive intramuscular injections
- History of pericarditis, myocarditis, serositis, bacterial heart valve infection, or macrophage activation syndrome within 6 months before screening
- Presence of other rheumatic or autoinflammatory diseases such as Kawasaki disease, polyarteritis nodosa, familial Mediterranean fever, high IgD syndrome, or NLRP3-related diseases
- History of interstitial lung disease, pulmonary fibrosis, alveolar proteinosis, pulmonary hypertension, or repeated invasive fungal infections
- Recent infections within 7 days before randomization requiring systemic antimicrobial treatment
- History of tuberculosis exposure or suspected tuberculosis symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Children's Hospital Affiliated to Capital Medical University
Beijing, Benjing, China, 100045
Actively Recruiting
2
Children's Hospital Affiliated to Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400015
Not Yet Recruiting
3
Hunan Children's Hospital
Changsha, Hunan, China, 410323
Not Yet Recruiting
4
Children's Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China, 210008
Not Yet Recruiting
5
Children's Hospital of Soochow University
Suzhou, Jiangsu, China, 215002
Not Yet Recruiting
6
Affiliated Pediatric Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Not Yet Recruiting
7
Xi'an Children's Hospital
Xi’an, Shanxi, China, 710002
Not Yet Recruiting
8
Chengdu Women and Children's Central Hospital
Chengdu, Sichuan, China, 610073
Not Yet Recruiting
9
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
10
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325099
Not Yet Recruiting
Research Team
L
Lijun Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here