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 oppdatert 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Lanlan Geng, Doctor
- Telefonnummer: 18902268612
- E-post: 13622237569@163.com
Studiesteder
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-
Guangdong
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Guangzhou, Guangdong, Kina, 510600
- Rekruttering
- Women and Children's Medical Center, Guangzhou Medical University
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Ta kontakt med:
- Lanlan Geng, Doctor
- Telefonnummer: 18902268612
- E-post: 13622237569@163.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting.
Tidsramme: 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
Tidsramme: 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
|
Weeks 12, 26, 52
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Changes in C-reactive protein (CRP) levels
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. august 2026
Primær fullføring (Antatt)
1. mars 2029
Studiet fullført (Antatt)
1. mars 2029
Datoer for studieregistrering
Først innsendt
24. april 2026
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ADM-IV-01
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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