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

NCT ID: NCT03301883

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2022-08-05

Brief 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.

Conditions

Juvenile Idiopathic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab

Participants weighing greater than or equal to (\>/=) 30 kilograms (kg) will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W), and participants weighing less than (\<) 30 kg will receive tocilizumab 12 mg/kg IV infusion Q2W for 52 weeks. After Week 12, the dose of tocilizumab can be adjusted for non-transient changes in body weight (shifting from \<30 to \>/=30 kg) over a minimum of three consecutive dosing visits. MTX, NSAIDs, and oral corticosteroids (CSs) are permitted but not required during the study.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

Tocilizumab will be administered as per the schedule specified in the arm description.

NSAIDs

Intervention Type: DRUG

Participants may receive NSAIDs up to the maximum recommended stable daily dose. Study protocol does not enforce any particular NSAID.

CSs

Intervention Type: DRUG

Participants may receive CSs at a stable dose of 30 milligrams per day (mg/day) or 0.5 milligrams per kilogram per day (mg/kg/day), whichever is less. Study protocol does not enforce any particular CS.

MTX

Intervention Type: DRUG

Participants may receive MTX at a stable dose of less than or equal to (\</=) 20 milligrams per square meter (mg/m\^2).

Interventions

Tocilizumab

Tocilizumab will be administered as per the schedule specified in the arm description.

Intervention Type: DRUG

NSAIDs

Participants may receive NSAIDs up to the maximum recommended stable daily dose. Study protocol does not enforce any particular NSAID.

Intervention Type: DRUG

CSs

Participants may receive CSs at a stable dose of 30 milligrams per day (mg/day) or 0.5 milligrams per kilogram per day (mg/kg/day), whichever is less. Study protocol does not enforce any particular CS.

Intervention Type: DRUG

MTX

Participants may receive MTX at a stable dose of less than or equal to (\</=) 20 milligrams per square meter (mg/m\^2).

Intervention Type: DRUG

Other Intervention Names

RO4877533

Eligibility Criteria

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
• History of atypical tuberculosis (TB)
• Active TB requiring treatment within 2 years prior to screening visit
• Positive purified protein derivative (PPD) or T-spot test (interferon-gamma [IFN-γ]-based test) at screen
• Positive for latent TB
• History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein-Barr virus (EBV) within 2 months of the screening visit
• Hepatitis B surface antigen (Ag)- or hepatitis C antibody (Ab)-positive
• History of macrophage activation syndrome (MAS) within 3 months prior to the screening visit
• Evidence of active malignant disease or diagnosed malignancies
• Uncontrolled diabetes mellitus
• Previous treatment with tocilizumab
• Intra-articular, intramuscular, IV, or long-acting CSs administration within 28 days prior to the baseline visit
• Treatment with non-biologic disease-modifying antirheumatic drugs (DMARDs; other than MTX) within 6 weeks prior to the baseline visit
• Treatment with leflunomide that was not followed by standardized cholestyramine washout and documented to be below the limit of detection prior to the baseline visit
• Treatment with cyclophosphamide, etoposide (VP16) and statins within 90 days prior to the baseline visit
• Treatment with growth hormone and androgens within 4 weeks prior to the baseline visit
• Administration of IV immunoglobulin within 28 days prior to the baseline visit
• Treatment with any cell-depleting therapies
• Stem cell transplant at any time
• Participant who has received live or attenuated vaccines within 4 weeks prior to the baseline visit, or intending to receive while on study drug or 3 months following the last dose of study drug

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

Countries

China

Other Identifiers

YA39368

Identifier Type: -

Identifier Source: org_study_id