RecruitingPhase 4interventionalRules rewrite

Phase 4: testing TyboWe® Adalimumab Injection for Crohn's Disease

This is a post-marketing real-world study designed to measure the how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07663526 · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · enrollment listed as 50

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TyboWe® Adalimumab Injection. The registry lists allocation as na. This is a post-marketing real-world study designed to measure the how well it works and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial.

They plan to enroll about 50 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: TyboWe® Adalimumab Injection

Primary outcome (registry wording): Serious Adverse Event (SAE)

Who it is for (from inclusion criteria)

Ages 18 Years to 70 Years
Aged 18 to 70 years inclusive, no gender restriction
Adult patients with Crohn's disease who are prescribed Tabellvi® Adalimumab Injection by physicians following thorough risk-benefit assessment
Female subjects of childbearing potential must agree to use one contraceptive method approved by the investigator

Who the registry excludes

Subjects who are not suitable for treatment with Tabellvi® Adalimumab Injection based on the prescribing information of Tabellvi® Adalimumab Injection and the judgment of the treating physician
Female subjects who are pregnant or breastfeeding, or who plan to become pregnant during the study period
Subjects with hypersensitivity to any component of Tabellvi® Adalimumab Injection
Subjects with active, chronic or recurrent infections, or a medical history of invasive infections (e.g., listeriosis, histoplasmosis)
Subjects with active infections requiring intravenous anti-infective therapy within 30 days prior to the first dose, or those who have received oral anti-infective drugs within 14 days prior to the first dose
Subjects with syphilis infection requiring treatment
Subjects with moderate to severe heart failure (NYHA Class III/IV), recent cerebrovascular accident, or other medical conditions that may put the subject at risk by participating in this study

Public study contact (from the registry)

Jun Shen, Doctor

13651829887

shenjun@vip.163.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

7 listed

Fuyang People's Hospital — Fuyang, Anhui, China (not_yet_recruiting)
The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (not_yet_recruiting)
Zhoukou Central Hospital — Zhoukou, Henan, China (not_yet_recruiting)
Huai'an First People's Hospital — Huaian, Jiangsu, China (not_yet_recruiting)
Yancheng No.1 People's Hospital — Yancheng, Jiangsu, China (not_yet_recruiting)
Meihekou Central Hospital — Meihekou, Jilin, China (not_yet_recruiting)
Shanghai Jiao Tong University School of Medicine, Renji Hospital — Shanghai, Shanghai Municipality, China (recruiting)

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FAQ about this NCT record

Is NCT07663526 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07663526?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07663526?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary