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CompletedNCT00055536Updated Jun 16, 2016

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

A Phase 2 interventional study of natalizumab in Crohn's Disease, sponsored by Biogen. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-16.

Sponsored by Biogen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Crohn's Disease

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 60 is close to the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

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 patients at least 18 years of age with at least a six-month history of Crohn's disease and who are currently receiving Remicade and are not in remission (CDAI greater than/equal to 150)
  • Women must not be breastfeeding or pregnant, and must not become pregnant during the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
60 participants

Interventions

  • Drugnatalizumab
06

Study locations

18 sites
  • Digestive Disease Associates
    Gainesville, Florida 32605, United States
  • Borland Groover Clinic
    Jacksonville, Florida 32223, United States
  • Atlanta Gastroenterology Associates
    Atlanta, Georgia 30342, United States
  • University of Kentucky Medical Center
    Lexington, Kentucky 40536, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Mercury Street Medical
    Butte, Montana 59701, United States
  • Long Island Clinical Research Associates, LLP
    Great Neck, New York 11021, United States
  • Asheville Gastroenterology
    Asheville, North Carolina 28801, United States
  • Wake Research Associates
    Raleigh, North Carolina 27612, United States
  • Boice-Willis Clinic
    Rocky Mount, North Carolina 27804, United States
  • Columbia Gastroenterology Associates
    Columbia, South Carolina 29203, United States
  • Gastroenterology Center of the MidSouth
    Memphis, Tennessee 38120, United States
  • Memphis Gastroenterology Group
    Memphis, Tennessee 38120, United States
  • Austin Gastroenterology
    Austin, Texas 78745, United States
  • Internal Medicine Associates
    Danville, Virginia 24541, United States
  • Gastroenterology Consultants
    Virginia Beach, Virginia 23455, United States
  • Virginia Mason Medical Center
    Seattle, Washington 98101, United States
  • Digestive Health Specialists
    Tacoma, Washington 98405, United States
07

Updates

Tracking since Sep 25, 2026
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 ↗
08

Registry details

Key details

Study ID
NCT00055536
Lead sponsor
Biogen
Collaborators
Elan Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 6, 2003
Start date
Apr 2002
Primary completion
Jul 2003
Completion
Jul 2003
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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