Arthritis Clinical Trials

Find Arthritis Clinical Trials Near You

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.

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• 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: ≥1 case of arthritis, accompanied by or prior to ≥2 weeks of recurrent fever, including remittenor fever for ≥3 consecutive days (maximum daily body temperature ≥39 ° C, body temperature falling below 37 ° C between 2 heat peaks), accompanied by at least one of the following symptoms: ① a transient, non-fixed erythematous rash; ② systemic lymph node enlargement; Swelling of the liver and/or spleen; ④ Serositis.

• Agree to use effective means of contraception throughout the study period and for 6 months after the end of treatment.

Locations
Other Locations
China
Children's Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
Hunan Children's Hospital
NOT_YET_RECRUITING
Changsha
Chengdu Women and Children's Central Hospital
NOT_YET_RECRUITING
Chengdu
Children's Hospital Affiliated to Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Children's Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Children's Hospital Affiliated to Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Affiliated Pediatric Hospital of Fudan University
NOT_YET_RECRUITING
Shanghai
Children's Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
The Second Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Xi'an Children's Hospital
NOT_YET_RECRUITING
Xi’an
Contact Information
Primary
Lijun Tang
tanglijun@genscigroup.com
+86 18570616501
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2028-06-29
Participants
Target number of participants: 221
Treatments
Experimental: GenaKumab
15 subjects: GenaKumab 3.0mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w
Sponsors
Leads: Changchun GeneScience Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov