Crohn's DiseaseDEVELOPNCT00606346
A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
An observational study of Crohn's Disease and Ulcerative Colitis, run by Janssen Biotech, Inc. at 62 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis
- What is being tested?
- Anti TNF therapy including infliximab and No Biologics
- How many people
- 4,970 participants
- Where
- 62 sitesin 2 countries
- Study dates
- 31 May 2007to 30 Jun 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
62 sites in 2 countries.
62 sites in 2 countries
United States58 sites
Study site
Atlanta, Georgia
Study site
Aurora, Colorado
Study site
Boise, Idaho
Study site
Boston, Massachusetts
Study site
Boys Town, Nebraska
Study site
Brooklyn, New York
Study site
Buffalo, New York
Study site
Burlington, Vermont
Study site
Chapel Hill, North Carolina
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Danville, Pennsylvania
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Fairfax, Virginia
Study site
Fort Worth, Texas
Study site
Gainesville, Florida
Study site
Greenville, South Carolina
Study site
Hartford, Connecticut
Study site
Knoxville, Tennessee
Study site
Lake Success, New York
Study site
Las Vegas, Nevada
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Manchester, New Hampshire
Study site
Mays Landing, New Jersey
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Milwaukee, Wisconsin
Study site
Mineola, New York
Study site
Minneapolis, Minnesota
Study site
Mobile, Alabama
Study site
Morristown, New Jersey
Study site
New Haven, Connecticut
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Newton, Massachusetts
Study site
Norfolk, Virginia
Study site
Oakland, California
Study site
Oklahoma City, Oklahoma
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Portland, Maine
Study site
Rochester, Minnesota
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
Southfield, Michigan
Study site
Stony Brook, New York
Study site
Syracuse, New York
Study site
The Bronx, New York
Study site
Williamsville, New York
Study site
Worcester, Massachusetts
Canada4 sites
Study site
Burlington, Ontario
Study site
Edmonton, Alberta
Study site
Halifax, Nova Scotia
Study site
Toronto, Ontario
About this study
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.
Read the 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.
- Being tested
- Anti TNF therapy including infliximab, No Biologics
- Keywords
- Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Inflammatory Bowel Diseases, Immunomodulators, infliximab, TNF-alpha
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti TNF therapy including infliximabBiological
Treatments will be prescribed according to investigator judgement.
No BiologicsDrug
Treatments will be prescribed according to investigator judgement.
| Study group | Role | What they receive |
|---|---|---|
| Anti TNF therapy including infliximab | Treatments will be prescribed according to investigator judgement. Receives: Biological: Anti TNF therapy including infliximab | |
| No Biologics | Treatments will be prescribed according to investigator judgement. Receives: Drug: No Biologics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or indeterminate colitis [IC]).
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).
Measured: This is a 20-year registry that has visits every 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study start31 May 2007
- Primary completion15 Nov 2037 (estimated)
- Study completion30 Jun 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,970 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Services, L.L.C. Clinical Trial, Study director, Janssen Services, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606346
- Sponsor's protocol ID
- CR013912
- Other IDs
- C0168Z02
- Acronym
- DEVELOP
- Status last verified
- Nov 2026
- First submitted
- 21 Jan 2008
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00606346
- Acronym / sponsor ID
- DEVELOP / CR013912
- Keywords
- Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Inflammatory Bowel Diseases, Immunomodulators, infliximab, TNF-alpha
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,970 participants (actual)
- Lead sponsor
- Janssen Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2007 (actual)
- Primary completion
- 15 Nov 2037 (estimated)
- Study completion
- 30 Jun 2038 (estimated)
- First posted
- 1 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti TNF therapy including infliximab | – | Biological: Anti TNF therapy including infliximabTreatments will be prescribed according to investigator judgement. |
| No Biologics | – | Drug: No BiologicsTreatments will be prescribed according to investigator judgement. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti TNF therapy including infliximabTreatments will be prescribed according to investigator judgement. | Biological | Anti TNF therapy including infliximab |
| No BiologicsTreatments will be prescribed according to investigator judgement. | Drug | No Biologics |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Services, L.L.C. Clinical Trial study director
Janssen Services, L.L.C.
62 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Janssen Biotech, Inc. at 62 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.