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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Crohn's Disease

Thank you

Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease


Inclusion Criteria:



- Male or female subjects between the ages of 18 and 75 years at screening (upper age
limit will be 64 years in India and 65 years in the Netherlands).

- Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to
screening.

- Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a
baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.

Exclusion Criteria:

- Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings
suggestive of UC.

- Subjects diagnosed with Crohn's disease but without previous exposure to treatment
(i.e., treatment-naïve).

- Subjects receiving the following treatment for Crohn's disease:

- Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.

- Anti-TNFα therapy within 8 weeks prior to baseline.

- Interferon therapy within 8 weeks prior to baseline.

- Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.

- Intravenous corticosteroids within 2 weeks prior to baseline.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The proportion of subjects in clinical remission at week 8 as defined by a Crohn's disease activity index (CDAI) score of less than 150 points.

Outcome Time Frame:

week 8

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A3921083

NCT ID:

NCT01393626

Start Date:

October 2011

Completion Date:

October 2014

Related Keywords:

  • Crohn's Disease
  • Crohn Disease

Name

Location

University of Kentucky Lexington, Kentucky  40536-0098
University of Kentucky Chandler Medical Center Lexington, Kentucky  40536
Shands Hospital at the University of Florida Gainesville, Florida  32610
Center for Digestive Health Troy, Michigan  48098
Digestive Health Specialists of Tyler Tyler, Texas  75701
Regional Gastroenterology Associates of Lancaster, Ltd. Lancaster, Pennsylvania  17604
Digestive and Liver Disease Specialists Norfolk, Virginia  23502
Clinical Research Institute of Michigan, LLC Chesterfield, Michigan  48047
Sentara Leigh Hospital Norfolk, Virginia  23502
Southwest Gastroenterology New Lenox, Illinois  60451
Advanced Clinical Research Institute - Phase 1, LLC Anaheim, California  92801
AGMG Endoscopy Center Anaheim, California  92801
Shands Endoscopy Center Gainesville, Florida  32608
Drug Shipment Address Gainesville, Florida  32610
Shands Medical Plaza and Cancer Institute Gainsville, Florida  32610
Gastroenterology Group of Naples Naples, Florida  34102
Florida Medical Clinic, P.A. Zephyrhills, Florida  33542
Gastroenterology Associates of Central Georgia, LLC Macon, Georgia  31201
Surgical Centers of Michigan Troy, Michigan  48098
Utica Surgery Center Utica, Michigan  48317
Premier Medical Group of the Hudson Valley, PC Poughkeepsie, New York  12601
Charlotte Gastroenterology and Hepatology, PLLC Charlotte, North Carolina  28207
Charlotte Radiology Charlotte, North Carolina  28277
Dayton Gastroenterology, Inc. Dayton, Ohio  45415
Great Lakes Gastroenterology Mentor, Ohio  44060
The Endoscopy Center of Lake County Mentor, Ohio  44060
Endoscopy Center of Tyler Tyler, Texas  75701
University of Utah HSC Salt Lake City, Utah  84132
Cardiology Consultants Norfolk, Virginia  23502
Wisconsin Center for Advanced Research - GI Associates, LLC Milwaukee, Wisconsin  53215
The Center for Digestive Health Milwaukee, Wisconsin  53215