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COMPLETED Phase 2

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

NCT00055536 · View on ClinicalTrials.gov ↗

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

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

74 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. It is categorized as Phase 2, 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 60 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: NCT00055536 reports 18 study locations spanning 12 distinct geographic areas — top geographies include North Carolina, Florida, Tennessee. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00055536?

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 NCT00055536?

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 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.

Related

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