MedTrace Logo

Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

NCT00409617 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 945

Last updated 2011-10-10

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient general well-being, health-related quality of life (QoL), fistula healing, CD-related extra-intestinal manifestations, work performance, and overall activity.

Conditions

Interventions

BIOLOGICAL

adalimumab

Adalimumab 40 mg Every Other Week dosing

BIOLOGICAL

adalimumab

Adalimumab 40 mg Every Week dosing if participant experiences a disease flare or is not responding to treatment. A disease flare is defined as an increase of 3 points or more on the HBI compared to the Baseline score and a total HBI score of 7 or higher. Non-response is defined as a decrease by fewer than 3 points in the HBI compared to Baseline.

Sponsors & Collaborators

Principal Investigators

  • Paul Pollack, 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
2006-12-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Norway
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • Switzerland
  • 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 NCT00409617 on ClinicalTrials.gov