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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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