Status:

COMPLETED

A Study of Abatacept in Patients With Active Ulcerative Colitis

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Ulcerative Colitis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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. T...

Detailed Description

The Induction Period First Cohort (IP1C) arms (30/10 mg/kg and 10 mg/kg) were placebo-controlled arms that were used for the primary endpoint and its analysis. The Induction Period Second Cohort arms ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Men or women 18 years or older
  • Ulcerative colitis for at lease 3 months
  • Moderate to severe active ulcerative colitis
  • Inadequate response or intolerance to standard ulcerative colitis treatment

Exclusion

    Key Trial Info

    Start Date :

    December 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2009

    Estimated Enrollment :

    591 Patients enrolled

    Trial Details

    Trial ID

    NCT00410410

    Start Date

    December 1 2006

    End Date

    November 1 2009

    Last Update

    March 24 2015

    Active Locations (143)

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    Page 1 of 36 (143 locations)

    1

    University Of Alabama At Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Mayo Clinic Arizona

    Scottsdale, Arizona, United States, 85259

    3

    Cedars-Sinai Medical Center

    Los Angeles, California, United States, 90048

    4

    The Permanente Medical Group, Inc

    Sacramento, California, United States, 95825