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CompletedNCT00280956Updated Jun 16, 2016

Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease

A Phase 4 interventional study of natalizumab in Crohn's Disease, sponsored by Biogen. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-16.

Sponsored by Biogen · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
2,000
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this study is to evaluate the long-term tolerability and safety of natalizumab when administered a dose of 300 mg intravenously (IV) to subjects with Crohn's Disease who have previously participated in studies CD251, CD301, CD303, CD306, or CD307.

02

Conditions studied

  • Crohn's Disease

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03

In context

Crohn Disease

1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 66 across 1,212 interventional studies indexed under Crohn Disease.

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Lead sponsor

Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • Male and Female Subjects 18 years and older with Crohn's Disease who have participated in studies CD251, CD301, CD303, CD306, or CD307 per protocol
05

Study design

Phase
Phase 4
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. To evaluate the safety of natalizumab by the number and proportion of subjects with adverse events, and by assessing clinical laboratory parameters and vital signs.

07

Study locations

1 site
  • Performed only at CD251, CD301, CD303, CD306, and CD307 sites globally. No general public enrollment. The study is managed from the office of Elan Pharmaceuticals, Inc. in
    San Diego, California 92121, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2002, a primary completion of Sep 2004 and a completion of Sep 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2006
First posted
Jan 24, 2006
Start
Jul 2002
Primary completionActual
Sep 2004
CompletionActual
Sep 2004
Last update
Jun 16, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00280956
Lead sponsor
Biogen
Collaborators
Elan Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 24, 2006
Start date
Jul 2002
Primary completion
Sep 2004
Completion
Sep 2004
Last update
Jun 16, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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