A Study of Abatacept in Patients With Active Ulcerative Colitis - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00410410

Purpose

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

Condition	Intervention	Phase
Ulcerative Colitis	Drug: abatacept Drug: placebo	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis (UC) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Clinical response as defined by reduction in Mayo score [ Time Frame: after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Remission [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Mucosal Healing [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	636
Study Start Date:	December 2006
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 4 arms for induction period 2 arms for maintenance period	Drug: abatacept D5W, IV, 0, 3, ~10, 30, once monthly Induction Period 3 months Maintenance Period 12 months
2: Placebo Comparator 4 arms for induction period 2 arms for maintenance period	Drug: placebo NS, IV, ~10 mg/kg, once monthly Induction Period 3 months Maintenance Period 12 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410410

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 160 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-108
Study First Received:	December 11, 2006
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00410410
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Abatacept
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs

Antirheumatic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009