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A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
NCT00078611 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078611
The ClinicalTrials.gov registry entry for NCT00078611 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 462 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00078611 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00078611?
The interventions under investigation include: natalizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00078611?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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