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NCT00055536 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease

A Phase 2 study of Crohn's Disease, sponsored by Biogen.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target
18
Study locations

NCT00055536 is a Phase 2 study of Crohn's Disease that has completed, run by Biogen. The registered enrollment target is 60 participants, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (98% lower). The trial reports 18 study locations across 12 states.

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The verdict

NCT00055536, a Phase 2 study of Crohn's Disease, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target
18
Study locations

Study Summary

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.

Conditions Studied

Crohn's Disease

Interventions

  • DRUG natalizumab

Study Locations (18)

North Carolina

  • Asheville Gastroenterology - Asheville
  • Wake Research Associates - Raleigh
  • Boice-Willis Clinic - Rocky Mount

Florida

  • Digestive Disease Associates - Gainesville
  • Borland Groover Clinic - Jacksonville

Tennessee

  • Gastroenterology Center of the MidSouth - Memphis
  • Memphis Gastroenterology Group - Memphis

Virginia

  • Internal Medicine Associates - Danville
  • Gastroenterology Consultants - Virginia Beach

Washington

  • Virginia Mason Medical Center - Seattle
  • Digestive Health Specialists - Tacoma

Georgia

  • Atlanta Gastroenterology Associates - Atlanta

Kentucky

  • University of Kentucky Medical Center - Lexington

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2002-04
Est. Completion 2003-07
Phase Phase 2

Sponsor

Biogen

334 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00055536

The ClinicalTrials.gov registry entry for NCT00055536 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (98% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

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.

NCT00055536 reports 18 study locations spanning 12 distinct geographic areas - top geographies include North Carolina, Florida, Tennessee.

Frequently Asked Questions

What is clinical trial NCT00055536 about?

NCT00055536 is a clinical study titled "Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease". 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 c...

What is the current status of trial NCT00055536?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2002-04. Estimated completion is 2003-07.

What conditions does trial NCT00055536 study?

This clinical trial studies the following conditions: Crohn's Disease.

What interventions are being tested in trial NCT00055536?

The interventions under investigation include: natalizumab (DRUG).

Who is sponsoring clinical trial NCT00055536?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00055536 being conducted?

This trial has 18 study locations across Florida, Georgia, Kentucky, Massachusetts, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.