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Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

NCT00195715 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 777

Last updated 2011-07-12

Study results available
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Summary

To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

Conditions

Interventions

BIOLOGICAL

Adalimumab

Adalimumab 40 mg by subcutaneous injection every other week or every week

Sponsors & Collaborators

Principal Investigators

  • Anne Camez, MD · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-03-31
Completion
2008-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • South Africa
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00195715 on ClinicalTrials.gov