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A Study of Abatacept in Patients With Active Ulcerative Colitis

NCT00410410 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 591

Last updated 2015-03-24

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 ulcerative colitis 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 (ABA)

Dextrose 5% in water, IV. Placebo on days 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 (ABA 30/\~10 mg/kg Group). 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, once monthly Open- Label Extension Period until the drug is marketed for UC or the UC 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
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-06-30
Completion
2009-11-30

Countries

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

Study Locations

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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 NCT00410410 on ClinicalTrials.gov