Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
Public ClinicalTrials.gov record NCT00055536. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease. Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-351.
Study identification
- NCT ID
- NCT00055536
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2002 (Type not available)
- Primary completion
- Jul 2003 (Actual)
- Completion
- Jul 2003 (Actual)
- Last update posted
- Jun 16, 2016
2002 – 2003
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Disease Associates | Gainesville | Florida | 32605 | — |
| Borland Groover Clinic | Jacksonville | Florida | 32223 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Mercury Street Medical | Butte | Montana | 59701 | — |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | — |
| Asheville Gastroenterology | Asheville | North Carolina | 28801 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Boice-Willis Clinic | Rocky Mount | North Carolina | 27804 | — |
| Columbia Gastroenterology Associates | Columbia | South Carolina | 29203 | — |
| Gastroenterology Center of the MidSouth | Memphis | Tennessee | 38120 | — |
| Memphis Gastroenterology Group | Memphis | Tennessee | 38120 | — |
| Austin Gastroenterology | Austin | Texas | 78745 | — |
| Internal Medicine Associates | Danville | Virginia | 24541 | — |
| Gastroenterology Consultants | Virginia Beach | Virginia | 23455 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Digestive Health Specialists | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00055536, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 16, 2016 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00055536 live on ClinicalTrials.gov.