Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00409682 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 192
- Enrollment target
- 20
- Study locations
NCT00409682: Completed Phase 3 study of Crohn's Disease, sponsored by Abbott.
NCT00409682 is a Phase 3 study of Crohn's Disease that has completed, run by Abbott. The registered enrollment target is 192 participants, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00409682, a Phase 3 study of Crohn's Disease, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 192 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
Primary Outcome
Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The primary endpoint was clinical remission as defined by PCDAI score ≤ 10. The comparison was b
Conditions Studied
Interventions
- BIOLOGICAL Adalimumab
Study Locations (20)
California
- Site Reference ID/Investigator# 10287 - Los Angeles
- Site Reference ID/Investigator# 5223 - Orange
- Site Reference ID/Investigator# 4984 - San Francisco
New York
- Site Reference ID/Investigator# 8801 - Buffalo
- Site Reference ID/Investigator# 3734 - Mineola
- Site Reference ID/Investigator# 4913 - New Hyde Park
Florida
- Site Reference ID/Investigator# 4911 - Orlando
- Site Reference ID/Investigator# 7640 - Orlando
Illinois
- Site Reference ID/Investigator# 4316 - Chicago
- Site Reference ID/Investigator# 5901 - Maywood
Minnesota
- Site Reference ID/Investigator# 5102 - Rochester
- Site Reference ID/Investigator# 4285 - Saint Paul
Colorado
- Site Reference ID/Investigator# 5222 - Aurora
Connecticut
- Site Reference ID/Investigator# 5676 - Hartford
Georgia
- Site Reference ID/Investigator# 5904 - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
What the finished NCT00409682 record still lists
NCT00409682 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Adalimumab is the first listed.
NCT00409682 names 20 study sites across 13 states, led by California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT00409682 about?
NCT00409682 is a clinical study titled "Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease". The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
What is the current status of trial NCT00409682?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 192 participants. The study started on 2007-04. Estimated completion is 2010-05.
What conditions does trial NCT00409682 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT00409682?
The interventions under investigation include: Adalimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00409682?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00409682 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00409682's enrollment target sits among peer trials
192 54th of 105 higher than 52 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
RECRUITING · Phase 3
-
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
RECRUITING · Phase 3
-
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
RECRUITING · Phase 3
-
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
RECRUITING · Phase 3
-
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
RECRUITING · Phase 3
-
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01492972 · 192 participants · Phase 3
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
- NCT01973881 · 192 participants
Quantitative MRI for Myelofibrosis
- NCT02535702 · 192 participants · NA
Development Of Neuroimaging Methods To Assess The Neurobiology Of Addiction
- NCT03622359 · 192 participants · NA
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia