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COMPLETEDPHASE4

A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)

A Phase IV, Multicenter, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Tocilizumab in Chinese Patients With Systemic Juvenile Idiopathic Arthritis

NCT03301883•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This Phase IV, multicenter, single-arm, open-label study will evaluate the efficacy and safety of tocilizumab in Chinese participants with sJIA with persistent activity and an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) and steroid therapy.

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants meeting International League of Associations for Rheumatology (ILAR) classification for sJIA
•Greater than (\>) 6 months of documented persistent sJIA activity prior to screening
•Active disease
•hsCRP \>4.3 milligrams per liter (mg/L) or 0.43 milligrams per deciliter (mg/dL)
•Participant who has recovered from any symptomatic serositis for at least 30 days prior to the screening visit, and requires a dose of CSs at baseline of \</=30 mg/day or \</=0.5 mg/kg/day, whichever is less
•Participants meeting one of the following: Participant who is not receiving MTX or discontinued MTX \>/=4 weeks prior to baseline visit; participant who has been taking MTX \>/=12 weeks immediately prior to the baseline visit and on a stable dose of \</=20 mg/m\^2 for \>/=8 weeks prior to the baseline visit, together with either folic acid or folinic acid according to local standard of care
•Participant who was never treated with biologics or, if was previously treated with biologics, discontinued etanercept (or Yisaipu, Qiangke, or Anbainuo) \>/=2 weeks, infliximab or adalimumab \>/=8 weeks, anakinra \>/=1 week, or abatacept \>/=12 weeks prior to the baseline visit
•Participant who is not currently receiving oral CSs, or is taking oral CSs at a stable dose for \>/=2 weeks prior to the baseline visit at \</=30 mg/day or \</=0.5 mg/kg/day, whichever is less
•Participant who is not taking NSAIDs, or taking \</=1 type of NSAID at a stable dose for \>/=2 weeks prior to the baseline visit and is less than or equal to the maximum recommended daily dose

Exclusion Criteria

•Wheelchair bound or bedridden participant
•Any other autoimmune, rheumatic disease, or overlap syndrome other than sJIA
•Participant who is not fully recovered from recent surgery or \<6 weeks since surgery at the time of screening visit; or planned surgery during the initial 12 weeks of the study
•Lack of peripheral venous access
•Any significant concurrent medical or surgical condition that would jeopardize the participant's safety or ability to complete the trial
•Evidence of serious uncontrolled concomitant diseases
•Asthma for which the participant has required the use of oral or parenteral CSs for \>/=2 weeks within 6 months prior to the baseline visit
•Known human immunodeficiency (HIV) infection or other acquired forms of immune compromise or congenital conditions characterized by a compromised immune system
•Any active acute, subacute, chronic, or recurrent bacterial, mycobacterial, viral, or systemic fungal infection or opportunistic infection
•Any major episode of infection requiring hospitalization or treatment during screening, treatment with IV antibiotics completing within 4 weeks of the screening visit, or oral antibiotics completing within 2 weeks of the screening visit
+19 more criteria

Locations (10)

Capital Institute of Pediatrics

Beijing, China

Beijing Children's Hospital, Capital Medical University; rheumatism

Beijing, China

The First Hospital of Jilin University

Changchun, China

Children's Hospital Chongqing Medical university

Chongqing, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Pediatric Rheumatology division

Guangzhou, China

The Children's Hospibal ZheJiang University School of Medicine

Hangzhou, China

Chilren's hospital of nanjing medical university; Rheumatoid immunology

Nanjing, China

Shanghai Children's Medical Center; Renal rheumatology

Shanghai, China

Children's Hospital of Fudan University

Shanghai, China

The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical College

Wenzhou, China

Key Dates

Start Date

April 26, 2018

Primary Completion Date

September 4, 2021

Completion Date

August 5, 2022

Last Updated

January 30, 2024

Enrollment

ACTUAL participants

Conditions

Juvenile Idiopathic Arthritis

Interventions

Tocilizumab

DRUG

NSAIDs

DRUG

CSs

DRUG

MTX

DRUG

Dynamic Gait Index as a Functional Gait Assessment Measure in Children With JIA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)

Inclusion Criteria

Exclusion Criteria

Dynamic Gait Index as a Functional Gait Assessment Measure in Children With JIA

Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Medical Follow-up of New Cases of Polyarthritis in Children and Young Adults

Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis

Interest of an Adapted Physical Activity (APA) Program Among Patients With Juvenile Idiopathic Arthritis: a Feasibility and Efficacy Preliminary Study