AzTrials
AzTrials

Juvenile Idiopathic ArthritisPhase 4NCT03301883

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

A Phase 4 study testing Tocilizumab, NSAIDs and CSs in people with Juvenile Idiopathic Arthritis, run by Hoffmann-La Roche at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
Tocilizumab, NSAIDs and CSs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
10 sitesChina
Study dates
26 Apr 2018to 5 Aug 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Capital Institute of Pediatrics

    Beijing, 100020

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

    Beijing, 100045

  • The First Hospital of Jilin University

    Changchun, 130021

  • Children's Hospital Chongqing Medical university

    Chongqing, 400014

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

    Guangzhou, 510120

  • The Children's Hospibal ZheJiang University School of Medicine

    Hangzhou, 310052

  • Chilren's hospital of nanjing medical university; Rheumatoid immunology

    Nanjing, 210000

  • Shanghai Children's Medical Center; Renal rheumatology

    Shanghai, 200127

  • Children's Hospital of Fudan University

    Shanghai, 201102

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

    Wenzhou, 325000

Other trials in China

About this study

Official 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

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.

Being tested
Tocilizumab, NSAIDs, CSs, MTX
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Also called RO4877533

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

  • NSAIDsDrug

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

  • CSsDrug

    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.

  • MTXDrug

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

Study groups in NCT03301883
Study groupRoleWhat they receive
TocilizumabExperimentalParticipants 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.
Receives: Drug: Tocilizumab; Drug: NSAIDs; Drug: CSs; Drug: MTX

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 12

Secondary outcomes (13)

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

    Measured: Week 52

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

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: Baseline, Weeks 12, 24, and 52

  6. Mean Glucocorticoid Dose

    Measured: Baseline up to Week 52

  7. Mean Methotrexate (MTX) Dose

    Measured: Baseline up to Week 52

  8. Change From Baseline in Glucocorticoid Dose

    Measured: From Baseline to Week 52

  9. Change From Baseline in MTX Dose

    Measured: From Baseline to Week 52

  10. Pain Visual Analog Scale (VAS) Score

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

  11. Change From Baseline in Pain VAS Score

    Measured: 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

    Measured: Baseline up to Week 52

  13. Percentage of Participants With Adverse Events (AEs)

    Measured: Baseline up to end of study (up to Week 60)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2017
  2. Study start26 Apr 2018
  3. Primary completion4 Sep 2021
  4. Study completion5 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03301883
Sponsor's protocol ID
YA39368
Status last verified
Jan 2024
First submitted
21 Sep 2017
Last updated
30 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tocilizumab, NSAIDs and CSs in people with Juvenile Idiopathic Arthritis, run by Hoffmann-La Roche at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03301883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in