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Treatment of Chinese Adult Subjects With Moderate to Severe Crohn's Disease With Tabellvi®

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Primary endpoints: details revised at 1 of 5 entries · Start date changed from estimate of Aug 2026 to Sep 23, 2026 · Secondary endpoints: details revised at 1 of 5 entries · 2 more Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 5 entries
    • Start date changed from estimate of Aug 2026 to Sep 23, 2026
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised at 7 of 7 sites
    • Eligibility criteria expanded, about 3 words
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a post-marketing real-world study designed to evaluate the efficacy and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial. A total of 50 subjects are planned to be enrolled. The primary endpoints include the incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs) and serious ADRs, as well as the proportion of subjects achieving clinical remission (CDAI score \< 150) at Week 26.
Trial Details
NCT Number NCT07663526
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions Crohn's Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov