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A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of May 2026 to Aug 13, 2026 · Study title shortened, about 8 wordsv2 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2026 to Aug 13, 2026
    • Study title shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to evaluate the incidence of serious adverse events (SAEs) within 12, 26, and 52 weeks after treatment; as well as the incidence of adverse events (AEs), adverse drug reactions (ADRs), adverse events of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.
Trial Details
NCT Number NCT07564505
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov