Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00078611 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 462
- Enrollment target
- 20
- Study locations
NCT00078611: Completed Phase 3 study of Crohn's Disease, sponsored by Biogen.
NCT00078611 is a Phase 3 study of Crohn's Disease that has completed, run by Biogen. The registered enrollment target is 462 participants, below the 2,390-participant average among 105 other Crohn's Disease trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078611, a Phase 3 study of Crohn's Disease, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 462 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.
Conditions Studied
Interventions
- DRUG natalizumab
Study Locations (20)
California
- Advanced Clinical Research Institute - Anaheim
- Cedars-Sinai Medical Center - Los Angeles
- Digestive Diseases Foundation - Los Angeles
- David Geffen School of Medicine at UCLA, Division of Digestive Diseases - Los Angeles
- Community Clinical Trials - Orange
- UCSF / Mt. Zion IBD Center - San Francisco
- Shared Medical Research Foundation - Tarzana
Florida
- Malcolm Randall VA Medical Center - Gainesville
- Borland Groover Clinic - Jacksonville
- Miami Research Associates, Inc. - Miami
- Waterside Clinical Research Services, Inc. - West Palm Beach
- Shafran Gastroenterology Center - Winterpark
Colorado
- Lynn Institute of the Rockies - Colorado Springs
- Rocky Mountain Gastroenterology - Golden
- Arapahoe Gastroenterology - Littleton
Arizona
- Harmony Clinical Research - Oro Valley
- Advanced Clinical Therapeutics - Tucson
Connecticut
- Center for Medical Research, LLC - Manchester
District of Columbia
- Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo - Washington D.C.
Georgia
- Atlanta Gastroenterology Associates - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2004-03 |
| Est. Completion | 2005-03 |
| Phase | Phase 3 |
What the finished NCT00078611 record still lists
NCT00078611 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, below the 2,390-participant average among 105 other Crohn's Disease trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which natalizumab is the first listed.
NCT00078611 names 20 study sites across 7 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT00078611 about?
NCT00078611 is a clinical study titled "A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease". The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.
What is the current status of trial NCT00078611?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 462 participants. The study started on 2004-03. Estimated completion is 2005-03.
What conditions does trial NCT00078611 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT00078611?
The interventions under investigation include: natalizumab (DRUG).
Who is sponsoring clinical trial NCT00078611?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00078611 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. 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 NCT00078611's enrollment target sits among peer trials
462 27th of 105 higher than 79 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
- NCT00949819 · 462 participants
Active Surveillance for Cancer of the Prostate (ASCaP)
- NCT05126277 · 462 participants · Phase 3
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
- NCT04546399 · 461 participants · Phase 2
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
- NCT04787744 · 464 participants · Phase 2
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
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