Pediatric patients with a confirmed diagnosis of CD or UC . MedDRA version: 18.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Remicade
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Remsima and Inflectra
Concentration unit: mg
Sponsors
Janssen Biologics B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have a confirmed diagnosis of CD for at least 2 months. 2. Are male or female at least 6 years of age, but less than 17 years of age with the exception of patients who participated in the Sponsor's protocol C0168T72 or C0168T62. These patients are eligible for enrollment regardless of the patients age at the time of enrollment 3. The parent/legal guardian must be capable of providing written informed consent, and assent should be obtained from the child according to local regulations (age at which assent is given may vary by the IRB or EC). 4. The patient's physician expects the patient to be scheduled for a medical encounter (and/or other direct contact) at least every 6 months, as part of their usual care, at the time of enrollment. Are the trial subjects under 18? yes Number of subjects for this age range: 6000 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria may not be enrolled in the registry: 1. Are less than 6 years of age or 17 years of age or older with the exception of patients who participated in the Sponsor's protocol C0168T72 or C0168T62. These patients are eligible for enrollment regardless of the patients age at the time of enrollment 2. The patient and parent/guardian are not able to adhere to the protocol requirements. 3. Have other Crohn's-like diseases that are associated with genetic diseases (eg, glycogen storage disease). 4. Are participating in any clinical trial for an investigational agent that is not commercially available. 5. Are currently participating in one of the Sponsor's trials for pediatric IBD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this registry is to obtain long-term safety and clinical status information on pediatric patients with IBD (CD or UC).;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Canada, Netherlands, Sweden, United States
Contacts
Public ContactSite manager
MAPI
Outcome results
None listed