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A Study of Abatacept in Patients With Active Crohn's Disease

NCT00406653 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2010-09-14

Study results available
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Summary

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.

Conditions

Interventions

DRUG

abatacept

Dextrose 5% in water, intravenous (IV). Placebo on days Induction Period (IP)-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; \~10 mg/kg on days IP-1, IP-15,IP-29, IP-57, or 30 mg/kg on days IP-1,IP-15 and \~10 mg/kg on days IP-29, IP-57. Induction Period 3 months Maintenance Period 12 months

DRUG

placebo

Normal saline, IV, 0 mg/kg, every 28 days. Induction Period 3 months Maintenance Period 12 months

DRUG

abatacept

\~10 mg/kg, every 28 days. Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • India
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • South Africa
  • Switzerland

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 NCT00406653 on ClinicalTrials.gov