A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
NCT00606346 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4970
Last updated 2026-05-08
Summary
The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with Inflammatory Bowel Disease (IBD). Particular attention will be directed to recording safety outcomes reported in association with infliximab and other prescribed IBD therapies. In addition, information on disease status and quality of life will be collected.
Conditions
- Crohn's Disease
- Ulcerative Colitis
- Indeterminate Colitis
- Inflammatory Bowel Diseases
Interventions
- BIOLOGICAL
-
Anti TNF therapy including infliximab
Treatments will be prescribed according to investigator judgement.
- DRUG
-
No Biologics
Treatments will be prescribed according to investigator judgement.
Sponsors & Collaborators
-
Janssen Biotech, Inc.
lead INDUSTRY
Principal Investigators
-
Janssen Services, L.L.C. Clinical Trial · Janssen Services, L.L.C.
Eligibility
- Min Age
- 1 Month
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-05-31
- Primary Completion
- 2037-11-15
- Completion
- 2038-06-30
Countries
- United States
- Canada
Study Locations
More Related Trials
-
Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
NCT00833170 ·Status: COMPLETED
-
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
NCT01900574 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
NCT00336492 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease
NCT01559142 ·Status: UNKNOWN ·Phase: PHASE3
-
Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease
NCT03026582 ·Status: COMPLETED
-
Immune Function in Offsprings of Females With Inflammatory Bowel Disease
NCT02079441 ·Status: COMPLETED
-
Characterization of the Intestinal Microbiota in Patients With Inflammatory Bowel Disease and/or Spondyloarthritis and Study of the Impact of an Anti-TNF Alpha Therapy
NCT03359642 ·Status: COMPLETED ·Phase: NA
-
Top-down Infliximab Study in Kids With Crohn's Disease
NCT02517684 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
NCT05784246 ·Status: RECRUITING ·Phase: PHASE3
-
The Role of Gut Microbiome in Predicting Comorbidities and Complications in Children With Inflammatory Bowel Disease
NCT05652491 ·Status: WITHDRAWN
-
Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease
NCT07314606 ·Status: RECRUITING ·Phase: NA
-
Targeted Metabolomics to Decipher Dietary Contributions to Pediatric Inflammatory Bowel Disease (IBD) - Main Study
NCT05014243 ·Status: UNKNOWN
-
Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).
NCT02392221 ·Status: COMPLETED
-
The Role of Small Bowel Ultrasound in Initiation of Infliximab in Crohn's Disease Patients
NCT02330458 ·Status: UNKNOWN
-
EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis
NCT03679546 ·Status: COMPLETED ·Phase: PHASE4
-
Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease
NCT06954311 ·Status: RECRUITING
-
Fecal Microbiota Transplantation in Pediatric Patients
NCT02108821 ·Status: COMPLETED ·Phase: PHASE1
-
Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants.
NCT07172945 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Vascular Dysfunction in Paediatric IBD
NCT02161640 ·Status: COMPLETED
-
Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)
NCT00537316 ·Status: TERMINATED ·Phase: PHASE3
-
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
NCT02508012 ·Status: COMPLETED ·Phase: NA
-
IBD Disease Course of Infliximab-naïve IBD Patients Treated With Subcutaneous Infliximab CT-P13 Remsima®
NCT05722353 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease
NCT02566889 ·Status: TERMINATED ·Phase: PHASE4
-
COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
NCT07198113 ·Status: RECRUITING
-
Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis
NCT03765450 ·Status: ACTIVE_NOT_RECRUITING