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A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease (DEVELOP)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606346
Recruitment Status : Active, not recruiting
First Posted : February 1, 2008
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.

Tracking Information
First Submitted Date January 21, 2008
First Posted Date February 1, 2008
Last Update Posted Date March 18, 2020
Actual Study Start Date May 31, 2007
Estimated Primary Completion Date November 15, 2037   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2013)
Obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or indeterminate colitis [IC]). [ Time Frame: This is a 20-year registry that has visits every 6 months. ]
The objective of this registry is to obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or IC).
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
Official Title A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
Brief 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.
Detailed Description This registry study will include volunteer pediatric patients: approximately 2,000 pediatric patients with Crohn's Disease who have been treated with infliximab and approximately 2,000 pediatric patients with Crohn's Disease who have received therapies other than infliximab. Approximately 1,000 pediatric patients with Ulcerative Colitis or Indeterminant Colitis will also be enrolled. All patient treatments for IBD will be decided by the treating physicians in consultation with their patients based on usual clinical practice. Patient information will be collected at the time of enrollment and every 6 months for approximately 20 years. Data collection will include disease characteristics, IBD medications, safety assessments to include adverse events. Patients will also be asked to complete a brief questionnaire describing school and/or work attendance in order to assess quality of life. Some patients may be asked to participate in a substudy that will evaluate blood levels of formation of proteins that may develop after treatment with infliximab. A small amount of additional blood may be taken at the time of a routine blood draw that is part of a patient's routine medical care as determined by a treating physician. There are three studies as part of the post marketing requirement for IBD - C0168Z02, REMICADEPIB4002 and REMICADEPIB4003. There is one combined database for these protocols and analyses are performed using the aggregate data. All reports and publications will be generated from the combined database. No study agents will be administered in this registry. All patients will receive standard-of-care treatments prescribed by the patient's physician.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This is a registry of pediatric patients with IBD (e.g., CD, UC, or IC in C0168Z02 and CD in REMICADEPIB4002 and REMICADEPIB4003) who were treated with infliximab and/or other medical therapies for IBD. Information will be collected on patient demographics, disease characteristics, clinical status, quality of life, medications, and dose and frequency of administration of infliximab, other biologics, and immune modulators.
Condition
  • Crohn's Disease
  • Ulcerative Colitis
  • Indeterminate Colitis
  • Inflammatory Bowel Diseases
Intervention
  • 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.
Study Groups/Cohorts
  • Anti TNF therapy including infliximab
    Treatments will be prescribed according to investigator judgement.
    Intervention: Biological: Anti TNF therapy including infliximab
  • No Biologics
    Treatments will be prescribed according to investigator judgement.
    Intervention: Drug: No Biologics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 31, 2018)
4970
Original Estimated Enrollment
 (submitted: January 21, 2008)
5000
Estimated Study Completion Date June 30, 2038
Estimated Primary Completion Date November 15, 2037   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

C0168Z02 - Confirmed diagnosis of Crohn's disease, Ulcerative Colitis, or Indeterminate Colitis for at least 2 months 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).

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.

REMICADEPIB4002 and REMICADEPIB4003: Confirmed diagnosis of Crohn's disease or Ulcerative Colitis for at least 2 months

Exclusion Criteria:

C0168Z02: 17 years of age or older, with the exception of patients who participated in the Sponsor's conducted pediatric IBD clinical trials.

Have other Crohn's-like diseases that are associated with genetic diseases (eg, glycogen storage disease).

The patient and parent/guardian are not able to adhere to the protocol requirements.

Are participating in any clinical trial for an investigational agent that is not commercially available.

REMICADEPIB4002 and REMICADEPIB4003: Less than 6 years of age or 17 years of age or older.

Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00606346
Other Study ID Numbers CR013912
C0168Z02 ( Other Identifier: Janssen Biotech INC. )
REMICADEPIB4002 ( Other Identifier: Janssen Biotech INC. )
REMICADEPIB4003 ( Other Identifier: Janssen Biotech INC. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Janssen Biotech, Inc.
Study Sponsor Janssen Biotech, Inc.
Collaborators Not Provided
Investigators
Study Director: Janssen Services, L.L.C. Clinical Trial Janssen Services, L.L.C.
PRS Account Janssen Biotech, Inc.
Verification Date March 2020