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CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

NCT00707512 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 87

Last updated 2024-06-03

No results posted yet for this study

Summary

The primary objective of the study is to determine the incidence and pattern of serious and/or clinically significant infections, malignancies, and other serious adverse event (SAE) in participants with Crohn's Disease (CD) treated with natalizumab. The secondary objective of this study in this study population is to evaluate disease severity over time in participants with CD treated with natalizumab based on changes in the Harvey-Bradshaw Index (HBI).

Conditions

Interventions

DRUG

natalizumab

Administered as specified in the TOUCH Prescribing Program

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2015-05-28
Completion
2015-05-28

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707512 on ClinicalTrials.gov