A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis

Study acronym: ADVISE MCOS
StatusCompleted
PhaseNot specified
SponsorAbbVie
Started

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Record History

The 50 most recent of 96 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 2 of 3 entries Show 5 more changesShow less
    • Trial completed
    • Primary and study completion dates changed from estimate of Oct 2026 to Sep 2, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 52 of 55 entries
    • Study sites revised (140)
  2. Primary completion date: Oct 31, 2025 to Oct 2026
    • Study completion date: Oct 15, 2026 to Oct 2026
    • Site details revised at 24 of 140 sites
    v95
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 975 to confirmed 873
    • Study sites revised (140)
    v94
  4. Study sites revised (140)v93
  5. Site details revised at 35 of 140 sitesv92
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (140)v91
  2. Site details revised at 1 of 140 sitesv90
  3. Study sites: 139 to 140v89
  4. Study sites: 138 to 139v88
  5. Study sites revised (138)v87
  6. Study sites: 137 to 138v86
  7. Study sites: 135 to 137v85
  8. Study sites revised (135)v84
  9. Study sites: 134 to 135v83
  10. Study sites revised (134)v82
  11. Study sites revised (134)v81
  12. Study sites revised (134)v80
  13. Study sites revised (134)v79
  14. Study sites: 133 to 134
    • Study completion date: Aug 31, 2026 to Oct 15, 2026
    v78
  15. Study sites revised (133)v77
  16. Study sites revised (133)v76
  17. Study completion date: Jan 31, 2026 to Aug 31, 2026
    • Site details revised at 3 of 133 sites
    v75
  18. Study sites: 132 to 133v74
  19. Study sites: 120 to 132v73
  20. Study sites: 117 to 120v72
  21. Re-verified, no change to tracked fieldsv71
  22. Site details revised at 3 of 117 sitesv70
  23. Study sites: 116 to 117v69
  24. Study sites: 114 to 116v68
  25. Re-verified, no change to tracked fieldsv67
  26. Study sites: 112 to 114v66
  27. Study sites revised (112)v65
  28. Study sites revised (112)v64
  29. Study sites: 110 to 112v63
  30. Study sites: 109 to 110v62
  31. Study sites: 108 to 109v61
  32. Study sites: 107 to 108v60
  33. Study sites: 101 to 107v59
  34. Re-verified, no change to tracked fieldsv58
  35. Study sites: 100 to 101v57
  36. Study sites: 96 to 100
    • Primary completion date: Jan 31, 2026 to Oct 31, 2025
    v56
  37. Primary completion date: Oct 31, 2025 to Jan 31, 2026v55
  38. Re-verified, no change to tracked fieldsv54
  39. Study sites: 95 to 96v53
  40. Study sites: 128 to 95v52
  41. Site details revised at 1 of 128 sitesv51
  42. Re-verified, no change to tracked fieldsv50
  43. Study sites: 127 to 128v49
  44. Study sites: 124 to 127v48
  45. Study sites: 122 to 124v47
  • 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.
AbbVie
349 trials monitored
See 27 trials at risk
Atopic Dermatitis
500 trials monitored
See 18 trials at risk
Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, important information is missing on the use patterns and outcomes with upadacitinib in a real-world setting. Therefore, the purpose of this observational study is to help inform real-world usage patterns regarding the safety and effectiveness and duration of response of upadacitinib in adolescent and adult AD participants \>=12 years old in the real-world setting. Upadacitinib is an approved drug being developed for the treatment of AD. Around 975 adolescent and adult participants who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled worldwide. Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.
Trial Details
NCT Number NCT05081557
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Atopic Dermatitis
Related terms Dermatitis, Atopic
Enrollment 873 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov