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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT03301883
• Date of registration: 21/09/2017
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)
• Scientific 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
• Date of first enrolment: April 26, 2018
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03301883
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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 or
- 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 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 whichever is less

- Participant who is not taking NSAIDs, or taking 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-?]-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



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Juvenile Idiopathic Arthritis

Intervention(s)

Drug: CSs

Drug: Tocilizumab

Drug: MTX

Drug: NSAIDs

Primary Outcome(s)

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 Outcome(s)

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]

Mean Methotrexate (MTX) Dose [Time Frame: Baseline up to Week 52]

Pain Visual Analog Scale (VAS) Score [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

Mean Glucocorticoid Dose [Time Frame: Baseline up to Week 52]

Percentage of Participants Achieving JIA ACR30 Response With Absence of Fever, at Week 52 [Time Frame: Week 52]

Change From Baseline in MTX Dose [Time Frame: From Baseline to Week 52]

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]

Percentage of Participants Who Discontinue Permitted Concomitant Medication for sJIA [Time Frame: Baseline up to Week 52]

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]

Change From Baseline in Glucocorticoid Dose [Time Frame: From Baseline to 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 [Time Frame: Baseline, Weeks 12, 24, and 52]

Percentage of Participants With Adverse Events (AEs) [Time Frame: Baseline up to end of study (up to Week 60)]

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]

Secondary ID(s)

YA39368

Source(s) of Monetary Support

Please refer to primary and secondary sponsors