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

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Biogen

Status and phase

Completed
Phase 3

Conditions

Crohn's Disease

Treatments

Drug: natalizumab

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderate to severely active Crohn's disease. 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderate to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during this study. Patient enrollment requires previous participation in study AN100226-CD301 (please refer to the clinical trial listing for CD301).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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