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NOT YET RECRUITING
NCT07663526
PHASE4

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

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter, Single-Arm Study to Evaluate the Effectiveness and Safety of Tabellvi® (Adalimumab) in Chinese Adult Subjects With Moderate to Severe Active Crohn's Disease in the Real-World Setting

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-08

Completion Date

2029-03

Last Updated

2026-06-23

Healthy Volunteers

No

Conditions

Interventions

DRUG

TyboWe® Adalimumab Injection

Adalimumab is a human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking TNF-α, a core inflammatory factor in psoriasis.

Locations (7)

Fuyang People's Hospital

Fuyang, Anhui, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Zhoukou Central Hospital

Zhoukou, Henan, China

Huai'an First People's Hospital

Huaian, Jiangsu, China

Yancheng No.1 People's Hospital

Yancheng, Jiangsu, China

Meihekou Central Hospital

Meihekou, Jilin, China

Shanghai Jiao Tong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China