A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA) (NCT03301883) | Clinical Trial Compass
CompletedPhase 4
A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)
China62 participantsStarted 2018-04-26
Plain-language 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.
Who can participate
Age range2 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 week…
What they're measuring
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