drugset / Trial / NCT07564505

Post - Marketing Case Registration Study on the Safety and Efficacy of Adalimumab Solution for Injection in Chinese Pediatric Patients With Moderate - to - Severe Active Crohn's Disease

NCT07564505

Phase 4 Not yet recruiting 30 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-05
Primary completion
2029-03
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 20 mg
Subject Adalimumab Monoclonal antibody 40 mg

Indications

No indication recorded.