A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00615199

Purpose

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).

Condition	Intervention	Phase
Crohn's Disease	Drug: CP-690,550	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Clinical response defined by a decrease in the Crohn's disease activity index (CDAI) score of at least 70 points from baseline [ Time Frame: week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects achieving clinical remission defined as a reduction of CDAI score below 150 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
Clinical response defined by a decrease in the CDAI score of at least 100 points from baseline [ Time Frame: week 4 ] [ Designated as safety issue: No ]
Clinical response defined by a decrease in the CDAI score of at least 70 points from baseline [ Time Frame: week 1 and 2 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	December 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1mg BD: Placebo Comparator	Drug: CP-690,550 administration via oral route twice daily
5mg BD: Placebo Comparator	Drug: CP-690,550 administration via oral route twice daily
15mg BD: Placebo Comparator	Drug: CP-690,550 administration via oral route twice daily

Eligibility

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

Criteria

Inclusion Criteria:

Subjects must be at least 18 years of age at screening
Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
Subjects with moderate to severe Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive

Exclusion Criteria:

Subjects currently receiving immunosuppressants, interferon, anti-TNFa
Subjects with evidence of hematopoietic disorders
Subjects with evidence of active or latent TB

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615199

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 49 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3921043
Study First Received:	January 14, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00615199
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 14, 2009