RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Adalimumab Solution for Injection for Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease

This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to measure the incidence of serious side effects (SAEs) within 12, 26, and 52 weeks after treatment; as well as the incidence of side effects (AEs), adverse drug reactions (ADRs), side effects of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.

Official registry: https://clinicaltrials.gov/study/NCT07564505 · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · enrollment listed as 30

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 Adalimumab Solution for Injection. The registry lists allocation as na. This study is a real - world clinical research of adalimumab.

They plan to enroll about 30 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Post-marketing Case Registration Study on the Safety and Efficacy of Taibowei® Adalimumab Injection for Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease

Interventions: Adalimumab Solution for Injection

Primary outcome (registry wording): The incidence of adverse events (AE), adverse drug reactions (ADR), adverse events of special interest (AESI) and serious ADR at 12, 26 and 52 weeks after treatment

Who it is for (from inclusion criteria)

Ages 6 Years to 17 Years
Age is between 6 years old (inclusive) and 17 years old (inclusive), regardless of gender
Diagnosed as having moderate - to - severe active pediatric Crohn's disease according to the "Expert Consensus on the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease 2019"

Who the registry excludes

(1) According to the instruction manual of Adalimumab Solution for Injection and the judgment of the treating physician, the patient is not suitable for treatment with Adalimumab Solution for Injection
(2) Pediatric Crohn's disease patients who have received any live vaccines within 3 months prior to the first dose of Adalimumab Solution for Injection or who plan to receive any live vaccines during the study period
Patients who are participating in other clinical studies. (4) Patients whom the investigator deems unsuitable for participation in this trial

Public study contact (from the registry)

Lanlan Geng, Doctor

18902268612

13622237569@163.com

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

Sites listed on ClinicalTrials.gov

1 listed

Women and Children's Medical Center, Guangzhou Medical University — Guangzhou, Guangdong, China (recruiting)

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FAQ about this NCT record

Is NCT07564505 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 NCT07564505?

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 NCT07564505?

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