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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

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 ]

Enrollment:	239
Study Start Date:	January 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

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

Show 69 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ghoreschi K, Jesson MI, Li X, Lee JL, Ghosh S, Alsup JW, Warner JD, Tanaka M, Steward-Tharp SM, Gadina M, Thomas CJ, Minnerly JC, Storer CE, LaBranche TP, Radi ZA, Dowty ME, Head RD, Meyer DM, Kishore N, O'Shea JJ. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol. 2011 Apr 1;186(7):4234-43. Epub 2011 Mar 7.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00615199 History of Changes
Other Study ID Numbers:	A3921043
Study First Received:	January 14, 2008
Last Updated:	June 2, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012