Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05906576 |
Recruitment Status :
Recruiting
First Posted : June 18, 2023
Last Update Posted : April 11, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn Disease | Drug: Infliximab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients |
Actual Study Start Date : | September 21, 2023 |
Estimated Primary Completion Date : | November 2026 |
Estimated Study Completion Date : | February 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Infliximab
Infliximab for the treatment of Crohn's disease in children
|
Drug: Infliximab
Infliximab in the treatment of Crohn's disease in children
Other Name: CMAB008 |
- Clinical response rate at 14 weeks [ Time Frame: up to 14 weeks ]Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points
- Clinical remission rate at week 14 and 54 [ Time Frame: up to 54 weeks ]Clinical remission: PCDAI≤10
- Endoscopic response rate at week 14 and 54 [ Time Frame: up to 54 weeks ]Endoscopic response: SES-CD decreased ≥ 50%
- Mucosal healing rate at week 14 and 54 [ Time Frame: up to 54 weeks ]Mucosal healing: SES-CD 0-2
- 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 [ Time Frame: 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.
- Changes from baseline in serum C-reactive protein at week 14 and 54 [ Time Frame: up to 54 weeks ]Changes from baseline in serum C-reactive protein at week 14 and 54
- Changes from baseline in erythrocyte sedimentation rate at week 14 and 54 [ Time Frame: up to 54 weeks ]Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
- Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks [ Time Frame: 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
- ADA positive rate [ Time Frame: up to 54 weeks ]ADA positive rate at week 14 and 54
- Percentage of participants with Adverse Events [ Time Frame: up to 102 weeks ]Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05906576
Contact: Wu Jie | 18940251108 | licli2860@sina.com |
China | |
Beijing Children's Hospital, Capital Medical University | Recruiting |
Beijing, China | |
Contact: Wu Jie 18940251108 licli2860@sina.com |
Principal Investigator: | Wu Jie | Beijing Children's Hospital |
Responsible Party: | Taizhou Mabtech Pharmaceutical Co.,Ltd |
ClinicalTrials.gov Identifier: | NCT05906576 |
Other Study ID Numbers: |
C008CDIV |
First Posted: | June 18, 2023 Key Record Dates |
Last Update Posted: | April 11, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Infliximab Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Dermatologic Agents Gastrointestinal Agents Antirheumatic Agents |