Registerstudie etter markedsføring av infliksimab til injeksjon hos kinesiske pediatriske pasienter med Crohns sykdom
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
Studieoversikt
Detaljert beskrivelse
This is a prospective, multicenter registry study in Chinese pediatric Crohn's disease patients. A total of 30 subjects were planned to be enrolled and treated with Infliximab. Subjects were observed for 102 weeks after administration to evaluate the clinical efficacy and safety of infliximab in the treatment of children with Crohn's disease in a real diagnostic setting.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Wu Jie
- Telefonnummer: 18940251108
- E-post: licli2860@sina.com
Studiesteder
-
-
-
Beijing, Kina
- Rekruttering
- Beijing Children's Hospital, Capital Medical University
-
Ta kontakt med:
- Wu Jie
- Telefonnummer: 18940251108
- E-post: licli2860@sina.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age ranged 6 to 17 years (both inclusive), no gender limitation.
- A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition).
- Patients and/or their guardians must sign ICF, and the research agreement/ICF for data collection and data verification shall comply with local laws and regulations.
- The patient received infliximab for the first time.
Exclusion Criteria:
- Patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product.
- Those who accept other anti-TNF-α any biological drugs or any other biologicals.
- Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
- Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
- The investigator judges the subject inappropriate to be included in this study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Infliximab
Infliximab for the treatment of Crohn's disease in children |
Infliximab in the treatment of Crohn's disease in children
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical response rate at 14 weeks
Tidsramme: up to 14 weeks
|
Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points |
up to 14 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical remission rate at week 14 and 54
Tidsramme: up to 54 weeks
|
Clinical remission: PCDAI≤10 |
up to 54 weeks
|
|
Endoscopic response rate at week 14 and 54
Tidsramme: up to 54 weeks
|
Endoscopic response: SES-CD decreased ≥ 50% |
up to 54 weeks
|
|
Mucosal healing rate at week 14 and 54
Tidsramme: up to 54 weeks
|
Mucosal healing: SES-CD 0-2 |
up to 54 weeks
|
|
Changes from baseline in height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score at week 14 and 54
Tidsramme: up to 54 weeks
|
The z-score is converted from anthropometric measurements based on the World Health Organization growth reference. The z-score including: height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score. |
up to 54 weeks
|
|
Changes from baseline in serum C-reactive protein at week 14 and 54
Tidsramme: up to 54 weeks
|
Changes from baseline in serum C-reactive protein at week 14 and 54 |
up to 54 weeks
|
|
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
Tidsramme: up to 54 weeks
|
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54 |
up to 54 weeks
|
|
Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks
Tidsramme: up to 54 weeks
|
Delayed development: Female children over 13 years old and male children over 14 years old are in the Tanner stage I |
up to 54 weeks
|
|
ADA positive rate
Tidsramme: up to 54 weeks
|
ADA positive rate at week 14 and 54 |
up to 54 weeks
|
|
Percentage of participants with Adverse Events
Tidsramme: up to 102 weeks
|
Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study |
up to 102 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Wu Jie, Beijing Children's Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- C008CDIV
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .