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NCT00055367 · ClinicalTrials.gov registry record · Phase 2

Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease

A Phase 2 study, sponsored by Biogen.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT00055367: Completed Phase 2 study, sponsored by Biogen.

NCT00055367 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00055367, a Phase 2 study, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD). 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 ELN100226-352.

Interventions

  • DRUG natalizumab

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2002-04
Est. Completion 2004-05
Phase Phase 2
Biogen

334 total trials

What the finished NCT00055367 record still lists

NCT00055367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which natalizumab is the first listed.

NCT00055367 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00055367 about?

NCT00055367 is a clinical study titled "Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease". The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD). It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. Th...

What is the current status of trial NCT00055367?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2002-04. Estimated completion is 2004-05.

What interventions are being tested in trial NCT00055367?

The interventions under investigation include: natalizumab (DRUG).

Who is sponsoring clinical trial NCT00055367?

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

How this trial's enrollment target compares

Where NCT00055367's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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

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Source: ClinicalTrials.gov NCT00055367, the US trial registry maintained by the National Library of Medicine. NCT00055367 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.