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ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 38 → 30 participants
    • Study description revised
    • Eligibility criteria shortened, about 2 words
    v26
  2. Eligibility criteria expanded, about 3 wordsv25
  3. Study sites: 12 to 14v24
  4. Primary completion date: Dec 2025 to Dec 2027
    • Study completion date: Dec 2027 to Dec 2029
    v23
  5. Study sites: 11 to 12v22
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites: 10 to 11v21
  2. Study sites: 9 to 10v20
  3. Site details revised at 1 of 9 sitesv19
  4. Eligibility criteria expanded, about 62 wordsv18
  5. Study sites: 14 to 9v17
  6. Study sites: 17 to 14v16
  7. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Dec 2026 to Dec 2027
    • Site details revised at 3 of 17 sites
    v15
  8. Site details revised at 2 of 17 sitesv14
  9. Re-verified, no change to tracked fieldsv13
  10. Site details revised at 1 of 17 sitesv12
  11. Study sites: 18 to 17v11
  12. Site details revised at 1 of 18 sitesv10
  13. Site details revised at 1 of 18 sites
    • Eligibility criteria shortened, about 5 words
    v9
  14. Secondary endpoints: details revised at 2 of 4 entriesv8
  15. Study sites revised (18)v7
  16. Site contacts updated at 1 of 18 sitesv6
  17. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Nov 30, 2024 to Dec 2024
    • Study completion date: Nov 30, 2026 to Dec 2026
    • Start date changed from estimate of Nov 30, 2022 to Dec 16, 2022
    • Site details revised at 18 of 18 sites
  18. Start date: Aug 31, 2022 to Nov 30, 2022
    • Primary completion date: Aug 31, 2024 to Nov 30, 2024
    • Study completion date: Aug 31, 2026 to Nov 30, 2026
    v4
  19. Start date: Jun 15, 2022 to Aug 31, 2022
    • Primary completion date: Jun 15, 2024 to Aug 31, 2024
    • Study completion date: Jun 15, 2026 to Aug 31, 2026
    v3
  20. Start date: Apr 4, 2022 to Jun 15, 2022
    • Primary completion date: Apr 4, 2024 to Jun 15, 2024
    • Study completion date: Apr 4, 2026 to Jun 15, 2026
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
ACTEMRA (tocilizumab) is an IL-6 receptor antagonist used for the treatment of adult Rheumatoid Arthritis as well as Polyarticular (PJIA) and Systemic (SJIA) Juvenile Idiopathic Arthritis. In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.
Trial Details
NCT Number NCT05233397
Lead Sponsor Nationwide Children's Hospital
Collaborators: Children's Hospital Colorado
Conditions
(from sponsor)		 Adamantinomatous Craniopharyngioma, Recurrent Adamantinomatous Craniopharyngioma
Related terms Craniopharyngioma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov