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OpenTrials
Completed

NCT Number: NCT03301883

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

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Children's Hospital, Capital Medical University; rheumatism, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocilizumab

Drug

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

Other names: RO4877533

NSAIDs

Drug

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

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.

MTX

Drug

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

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

    Time frame: Week 12

Secondary outcomes

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

    Time frame: Week 52

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

    Time frame: Baseline, Weeks 12, 24, and 52

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

    Time frame: Weeks 24 and 52

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

    Time frame: Week 52

  5. 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

    Time frame: Baseline, Weeks 12, 24, and 52

  6. Mean Glucocorticoid Dose

    Time frame: Baseline up to Week 52

  7. Mean Methotrexate (MTX) Dose

    Time frame: Baseline up to Week 52

  8. Change From Baseline in Glucocorticoid Dose

    Time frame: From Baseline to Week 52

  9. Change From Baseline in MTX Dose

    Time frame: From Baseline to Week 52

  10. Pain Visual Analog Scale (VAS) Score

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  11. Change From Baseline in Pain VAS Score

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  12. Percentage of Participants Who Discontinue Permitted Concomitant Medication for sJIA

    Time frame: Baseline up to Week 52

  13. Percentage of Participants With Adverse Events (AEs)

    Time frame: Baseline up to end of study (up to Week 60)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Oct 4, 2017
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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