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Tests treatment safety and results for Active Systemic Juvenile Idiopathic Arthritis
Official title To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
ClinicalTrials.gov ID: NCT05925452
What this study is testing
What is GenaKumab?
GenaKumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for active systemic juvenile idiopathic arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Male and female patients, with the remaining before age 2 years old or more and \& lt; 18 years old;
- 2001 ILAR classification criteria for the diagnosis of confirmed sJIA 2 or more months: onset age must \& lt; At 16 years of age, symptoms included...
- Agree to use effective means of contraception throughout the study period and for 6 months after the end of treatment.
You likely can't join if
- Pregnant or lactating female people
- A history of allergic reactions to investigational drugs or to molecules with similar structures; Those who cannot be given intramuscular injections；
- History of pericarditis, myocarditis, serositis, bacterial heart valve or endocarditis within 6 months before screening; Patients who had been...
- There are other rheumatic diseases such as Kawasaki disease, polyarteritis nodosa and so on. History of autoinflammatory diseases such as familial...
- Patients with a history of interstitial lung disease, pulmonary fibrosis, alveolar proteinosis, or pulmonary hypertension; Patients with a history of...
- people with a history of TB exposure or suspected TB symptoms.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Benjing, China
- Chongqing, Chongqing Municipality, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Xi’an, Shanxi, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Benjing, China; Chongqing, Chongqing Municipality, China; Changsha, Hunan, China; Nanjing, Jiangsu, China; Suzhou, Jiangsu, China; Shanghai, Shanghai Municipality, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.