Not yet recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adalimumab Solution for Injection.
- Who it may be relevant to
- Registry conditions: Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Adalimumab Solution for Injection
Adalimumab is a fully human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking Tumor Necrosis Factor-α (TNF-α), a core inflammatory factor in psoriasis.
Primary outcome measures
- 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 [Time frame: Weeks 12, 26, 52]
Secondary outcome measures (7)
- Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting. [Time frame: Weeks 12, 26, 52]
- Proportion of patients with clinical response [Time frame: Weeks 12, 26, 52]
- Changes in C-reactive protein (CRP) levels [Time frame: Weeks 12, 26, 52]
- Changes in fecal calprotectin (FC) levels [Time frame: Weeks 12, 26, 52]
- Effective trough concentration of adalimumab [Time frame: week 4]
- Growth and development of pediatric patients-Weight [Time frame: Weeks 12, 26, 52]
- Growth and development of pediatric patients-Height [Time frame: Weeks 12, 26, 52]
Eligibility criteria
Inclusion criteria
- 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".
- (3) Pediatric Crohn's disease patients who have been prescribed Adalimumab Solution for Injection by doctors after a full assessment of risks/benefits.Both the patient and their guardian must sign the informed consent form. The research protocol/informed consent form used for data collection and data verification should comply with local laws and regulatory requirements.
Exclusion criteria
- (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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07564505 · ADM-IV-01