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

NCT03301883 | Completed Phase 4

• 1 other identifier: YA39368
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (JIA ACR30) Response With Absence of Fever, at Week 12

  Week 12

Secondary Outcomes (13)

• Percentage of Participants Achieving JIA ACR30 Response With Absence of Fever, at Week 52

  Week 52

• Percentage of Participants With 30 Percent (%), 50%, 70%, and 90% Improvement From Baseline in JIA Core Set Parameters

  Baseline, Weeks 12, 24, and 52

• Percentage of Participants With Inactive Disease Assessed According to Criteria for Inactive Disease and Clinical Remission of sJIA (Wallace et. al. 2011 Criteria)

  Weeks 24 and 52

• Percentage of Participants With Clinical Remission Assessed According to Criteria for Inactive Disease and Clinical Remission of sJIA (Wallace et. al. 2011 Criteria)

  Week 52

• Percentage of Participants With an Elevated High-Sensitivity C-Reactive Protein (hsCRP) Levels at Baseline Who Have Normal hsCRP Levels at Weeks 12, 24, and 52

  Baseline, Weeks 12, 24, and 52

Study Arms (1)

Tocilizumab

EXPERIMENTAL

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.

Drug: Tocilizumab; Drug: NSAIDs; Drug: CSs; Drug: MTX

Interventions

Tocilizumab DRUG

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

Also known as: RO4877533

Tocilizumab

NSAIDs DRUG

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

Tocilizumab

CSs 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.

Tocilizumab

MTX DRUG

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

Tocilizumab

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Capital Institute of Pediatrics

Beijing, 100020, China

Location

Beijing Children's Hospital, Capital Medical University; rheumatism

Beijing, 100045, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

Children's Hospital Chongqing Medical university

Chongqing, 400014, China

Location

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

Guangzhou, 510120, China

Location

The Children's Hospibal ZheJiang University School of Medicine

Hangzhou, 310052, China

Location

Chilren's hospital of nanjing medical university; Rheumatoid immunology

Nanjing, 210000, China

Location

Shanghai Children's Medical Center; Renal rheumatology

Shanghai, 200127, China

Location

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

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

Wenzhou, 325000, China

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

tocilizumab; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 4, 2017
• Study Start: April 26, 2018
• Primary Completion: September 4, 2021
• Study Completion: August 5, 2022
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CN (10)