A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease
6 september 2026 uppdaterad av: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Lanlan Geng, Doctor
- Telefonnummer: 18902268612
- E-post: 13622237569@163.com
Studieorter
-
-
Guangdong
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Guangzhou, Guangdong, Kina, 510600
- Rekrytering
- Women and Children's Medical Center, Guangzhou Medical University
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Kontakt:
- Lanlan Geng, Doctor
- Telefonnummer: 18902268612
- E-post: 13622237569@163.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Adalimumab Solution for Injection 20mg/40mg
For children with a body weight of ≥ 40 kg, the recommended loading dose is 160 mg. Then, 80 mg is given 2 weeks later, and subsequently, 40 mg is administered every 2 weeks for maintenance treatment. For children with a body weight of 17 - 40 kg, the loading dose is 80 mg. 40 mg is given 2 weeks later, and then 20 mg is administered every 2 weeks for maintenance treatment. If necessary, the dosing frequency can be increased to once a week according to the results of therapeutic drug monitoring and/or clinical response. |
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: Weeks 12, 26, 52
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The incidences 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
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Weeks 12, 26, 52
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting.
Tidsram: Weeks 12, 26, 52
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The proportion of patients achieving clinical remission (PCDAI ≤ 10 points) at 12, 26 and 52 weeks after treatment.
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Weeks 12, 26, 52
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Proportion of patients with clinical response
Tidsram: Weeks 12, 26, 52
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The proportion of patients with clinical response (PCDAI score decreased by ≥ 15 points compared to the baseline) at 12, 26, and 52 weeks after treatment
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Weeks 12, 26, 52
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Changes in C-reactive protein (CRP) levels
Tidsram: Weeks 12, 26, 52
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The changes in C - reactive protein (CRP) compared to the baseline level at 12, 26 and 52 weeks after treatment.
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Weeks 12, 26, 52
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Changes in fecal calprotectin (FC) levels
Tidsram: Weeks 12, 26, 52
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The changes in fecal calprotectin (FC) compared to the baseline level at 12, 26 and 52 weeks after treatment.
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Weeks 12, 26, 52
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Effective trough concentration of adalimumab
Tidsram: week 4
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The effective trough concentration of adalimumab before the third injection of adalimumab (at 4 weeks).
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week 4
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Growth and development of pediatric patients-Weight
Tidsram: Weeks 12, 26, 52
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Weight status of children's growth and development at Week 12, 26 and 52 after treatment .
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Weeks 12, 26, 52
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Growth and development of pediatric patients-Height
Tidsram: Weeks 12, 26, 52
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Height status of children's growth and development at Weeks 12, 26 and 52 after treatment.
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Weeks 12, 26, 52
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 augusti 2026
Primärt slutförande (Beräknad)
1 mars 2029
Avslutad studie (Beräknad)
1 mars 2029
Studieregistreringsdatum
Först inskickad
24 april 2026
Först inskickad som uppfyllde QC-kriterierna
29 april 2026
Första postat (Faktisk)
4 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ADM-IV-01
Läkemedels- och apparatinformation, studiedokument
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