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

January 18, 2013 updated by: Pfizer

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
  • Czech Republic
      • Hradec Kralove, Czech Republic, 50012
        • Pfizer Investigational Site
      • Usti nad Labem, Czech Republic, 401 13
        • Pfizer Investigational Site
  • France
      • Lille Cedex, France, 59037
        • Pfizer Investigational Site
      • Pessac Cedex, France, 33604
        • Pfizer Investigational Site
      • Vandoeuvre-les-nancy, France, 54511
        • Pfizer Investigational Site
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Pfizer Investigational Site
      • Debrecen, Hungary, 4004
        • Pfizer Investigational Site
      • Gyor, Hungary, 9023
        • Pfizer Investigational Site
      • Gyula, Hungary, 5701
        • Pfizer Investigational Site
      • Kaposvar, Hungary, 7400
        • Pfizer Investigational Site
      • Szekszard, Hungary, 7100
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
      • Roma, Italy, 00152
        • Pfizer Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Pfizer Investigational Site
  • Poland
      • Lublin, Poland, 20-954
        • Pfizer Investigational Site
      • Olsztyn, Poland, 10-561
        • Pfizer Investigational Site
      • Wroclaw, Poland, 50-556
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 811 07
        • Pfizer Investigational Site
      • Nitra, Slovakia, 94901
        • Pfizer Investigational Site
  • South Africa
      • Durban, South Africa, 4091
        • Pfizer Investigational Site
    • Cape Town
      • Durbanvilee, Cape Town, South Africa
        • Pfizer Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Pfizer Investigational Site
    • Kwa-Zulu Natal
      • Durban, Kwa-Zulu Natal, South Africa, 4001
        • Pfizer Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7708
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28922
        • Pfizer Investigational Site
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Pfizer Investigational Site
      • Salford, United Kingdom, M6 8HD
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36617
        • Pfizer Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Pfizer Investigational Site
      • Lakewood, Colorado, United States, 80215
        • Pfizer Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Pfizer Investigational Site
      • Boca Raton, Florida, United States, 33486
        • Pfizer Investigational Site
      • Boca Raton, Florida, United States, 33442
        • Pfizer Investigational Site
      • Boca Raton, Florida, United States, 33496
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32607
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32605
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Pfizer Investigational Site
      • St. Petersburg, Florida, United States, 33709
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67208
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Pfizer Investigational Site
      • Towson, Maryland, United States, 21204
        • Pfizer Investigational Site
    • Michigan
      • Troy, Michigan, United States, 48098
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Pfizer Investigational Site
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Pfizer Investigational Site
    • New York
      • Great Neck, New York, United States, 11021
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • Pfizer Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • Pfizer Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45415
        • Pfizer Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • Pfizer Investigational Site
      • Upper St. Clair,, Pennsylvania, United States, 15241
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Pfizer Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37205
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-8887
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Pfizer Investigational Site
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo BID
Drug: Placebo
administration via oral route twice daily
Experimental: 1mg BD
Drug: CP-690,550
administration via oral route twice daily
Experimental: 5mg BD
Drug: CP-690,550
administration via oral route twice daily
Experimental: 15mg BD
Drug: CP-690,550
administration via oral route twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Response 70 at Week 4
Time Frame: Week 4
Clinical response 70: defined as a reduction in Crohn's Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Response 70 at Week 1 and 2
Time Frame: Week 1, 2
Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Week 1, 2
Number of Participants Achieving Clinical Remission at Week 4
Time Frame: Week 4
Clinical remission=CDAI at Week 4 less than (<) 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Week 4
Number of Participants With Clinical Response 100 at Week 4
Time Frame: Week 4
Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Week 4
Time to First Clinical Remission
Time Frame: Week 1 through Week 4
Clinical remission=CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Week 1 through Week 4
Time to First Response 70
Time Frame: Week 1 through Week 4
Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 , higher score indicates higher disease activity.
Week 1 through Week 4
Time to First Response 100
Time Frame: Week 1 through Week 4
Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Week 1 through Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

January 25, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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