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A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 102 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv102
  2. Trial status changed: Recruiting → Active, Not Recruiting Primary and study completion pushed from Sep 2026 to Oct 2026 · Site details revised at 55 of 55 sitesv101 Show 2 more changesShow less
    • Primary and study completion pushed from Sep 2026 to Oct 2026
    • Site details revised at 55 of 55 sites
  3. Site details revised at 5 of 55 sitesv100
  4. Site details revised at 16 of 55 sitesv99
  5. Study sites: 56 to 55v98
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 57 to 56 Primary completion date: Apr 2026 to Sep 2026 · Completion date: May 2026 to Sep 2026v97 Show 2 more changesShow less
    • Primary completion date: Apr 2026 to Sep 2026
    • Completion date: May 2026 to Sep 2026
  2. Site details revised at 1 of 57 sitesv96
  3. Study sites: 58 to 57v95
  4. Site details revised at 1 of 58 sitesv94
  5. Re-verified, no change to tracked fieldsv93
  6. Site details revised at 40 of 58 sitesv92
  7. Study sites: 59 to 58v91
  8. Study sites: 67 to 59v90
  9. Site details revised at 2 of 67 sitesv89
  10. Re-verified, no change to tracked fieldsv88
  11. Study sites: 65 to 67v87
  12. Eligibility criteria expanded, about 10 wordsv86 See this version in full on ClinicalTrials.gov ↗
  13. Primary completion date: Oct 2025 to Apr 2026 Completion date: Oct 2025 to May 2026 · Eligibility criteria revisedv85 Show 2 more changesShow less
    • Completion date: Oct 2025 to May 2026
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites revised (65)v84 See this version in full on ClinicalTrials.gov ↗
  15. Site details revised at 2 of 65 sitesv83
  16. Study sites: 64 to 65v82
  17. Enrollment target: 103 to 58 Primary endpoint revised · Study sites: 65 to 64 · Primary and study completion dates: Oct 27, 2025 to Oct 2025 · 5 morev81 Show 8 more changesShow less
    • Primary endpoint revised
    • Study sites: 65 to 64
    • Primary and study completion dates: Oct 27, 2025 to Oct 2025
    • Interventions: Baricitinib (Drug), Placebo (Drug) to Baricitinib (Drug), Tocilizumab (Drug)
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: 8 to 7
    • Study arms: 2 to 3
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  18. Study sites: 21 to 65v80
  19. Re-verified, no change to tracked fieldsv79
  20. Study sites: 65 to 21v78
  21. Primary and study completion dates: Aug 7, 2023 to Oct 27, 2025 Study sites: 67 to 65v77 Show 1 more changeShow less
    • Study sites: 67 to 65
  22. Study sites: 66 to 67v76
  23. Site details revised at 2 of 66 sitesv75
  24. 8 versions Re-verified since Nov 24, 2022, no change to tracked fieldsv67-v74
  25. Site details revised at 2 of 66 sitesv66
  26. Site details revised at 1 of 66 sitesv65
  27. Site details revised at 1 of 66 sitesv64
  28. Study sites: 69 to 66v63
  29. Site details revised at 2 of 69 sitesv62
  30. Re-verified, no change to tracked fieldsv61
  31. Site contacts updated at 1 of 69 sitesv60
  32. Study sites: 68 to 69v59
  33. Study sites: 67 to 68v58
  34. Study sites: 66 to 67v57
  35. Study sites: 65 to 66v56
  36. Site contacts updated at 1 of 65 sitesv55
  37. Eligibility criteria shortened, about 61 words Site contacts updated at 2 of 65 sitesv54 Show 1 more changeShow less
    • Site contacts updated at 2 of 65 sites

    See this version in full on ClinicalTrials.gov ↗

  38. Study sites revised (65)v53 See this version in full on ClinicalTrials.gov ↗
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Eli Lilly
359 trials monitored
See 15 trials at risk
The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.
Trial Details
NCT Number NCT04088396
Lead Sponsor Eli Lilly and Company
Conditions Systemic Juvenile Idiopathic Arthritis
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov