A Phase 4 interventional study of Tocilizumab and NSAIDs in Juvenile Idiopathic Arthritis, sponsored by Hoffmann-La Roche. Completed at 10 sites in China. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
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Among 21 studies testing tocilizumab in Arthritis, Juvenile — 2 open to participants now, 2 under way, 1 of them phase 3. tocilizumab · Arthritis, Juvenile.
Among the 21 studies testing tocilizumab in Arthritis, Juvenile, this one is the 6th largest by enrollment, is the only one that started in 2018, is one of 2 in phase 4, and was the 19th registered.
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
Browse Arthritis, Juvenile studies →2 of the 21 studies testing tocilizumab in Arthritis, Juvenile are open now, in 4 countries. Recruiting first, the newest first:
Duke University · Sites in United States, Germany, Italy and 1 more country
Ages 2–21
NYU Langone Health · Sites in United States
Ages 18+
By country, each count listing its studies:
tocilizumab: first FDA approval 2010 (ACTEMRA), first EMA approval 2009. What it is approved for, and how studies give it, is on its page →
Of the 69 Arthritis, Juvenile studies recruiting now, 13 (19%) set no upper age limit and 50 (72%) stop at 75 or younger; 65 take children under 18; 11 take healthy volunteers.
This study: 2 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 2 · Phase 3 12 · Phase 4 2
First in 2004; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 62 is above the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.
Median enrollment 52 across the 21 interventional studies. Of the 19 that completed or were terminated, 9 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 21 have an industry lead sponsor. The 7 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
17 studies in Arthritis, Juvenile by Hoffmann-La Roche: none open now, none under way, none of them phase 3. Of 17 finished, 7 (41%) have results posted.
Among the 17 studies in Arthritis, Juvenile by Hoffmann-La Roche, this one is the 4th largest by enrollment of the 16 interventional ones that give a count, is the only one that started in 2018, is one of 2 in phase 4, and was the 17th registered.
Hoffmann-La Roche’s Arthritis, Juvenile studies by the year they started, since 2000.
None of the studies under way reaches primary completion within a year.
Among the 21 studies testing tocilizumab in Arthritis, Juvenile, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Hoffmann-La Roche’s 17 in Arthritis, Juvenile:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Tocilizumab will be administered as per the schedule specified in the arm description.
Also known as: RO4877533
Participants may receive NSAIDs up to the maximum recommended stable daily dose. Study protocol does not enforce any particular NSAID.
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.
Participants may receive MTX at a stable dose of less than or equal to (\</=) 20 milligrams per square meter (mg/m\^2).
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
Percentage of Participants Achieving JIA ACR30 Response With Absence of Fever, at Week 52
Time frame: 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
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
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
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
Mean Glucocorticoid Dose
Time frame: Baseline up to Week 52
Mean Methotrexate (MTX) Dose
Time frame: Baseline up to Week 52
Change From Baseline in Glucocorticoid Dose
Time frame: From Baseline to Week 52
Change From Baseline in MTX Dose
Time frame: From Baseline 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
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 Adverse Events (AEs)
Time frame: Baseline up to end of study (up to Week 60)
Ran from Apr 2018 to primary completion in Sep 2021, 40 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tocilizumab