MedTrace Logo

Remission in Subjects With Crohn's Disease, 1 Year Phase

NCT00055497 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2011-04-11

Study results available
· View outcomes & findings →

Summary

The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks.

Conditions

Interventions

BIOLOGICAL

Double-blind (DB) adalimumab placebo

Double-blind nonactive matching subcutaneous injection

BIOLOGICAL

DB adalimumab 40 mg eow

Double-blind adalimumab 40 mg every other week by subcutaneous injection

BIOLOGICAL

DB adalimumab 40 mg ew

Double-blind adalimumab 40 mg every week by subcutaneous injection

BIOLOGICAL

OL adalimumab 40 mg

Open-label adalimumab every other week or every week by subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Anne Camez, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2005-01-31
Completion
2008-12-31

Countries

  • United States

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 NCT00055497 on ClinicalTrials.gov