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

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ClinicalTrials.gov Identifier: NCT00615199
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : December 31, 2012
Last Update Posted : January 25, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 14, 2008
First Posted Date  ICMJE February 14, 2008
Results First Submitted Date  ICMJE November 28, 2012
Results First Posted Date  ICMJE December 31, 2012
Last Update Posted Date January 25, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
  • Clinical response defined by a decrease in the CDAI score of at least 70 points from baseline [ Time Frame: week 1 and 2 ]
  • Percentage of subjects achieving clinical remission defined as a reduction of CDAI score below 150 [ Time Frame: Week 4 ]
  • Clinical response defined by a decrease in the CDAI score of at least 100 points from baseline [ Time Frame: Week 4 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease
Official Title  ICMJE 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.
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: CP-690,550
    administration via oral route twice daily
  • Drug: Placebo
    administration via oral route twice daily
Study Arms  ICMJE
  • Experimental: 1mg BD
    Intervention: Drug: CP-690,550
  • Experimental: 5mg BD
    Intervention: Drug: CP-690,550
  • Experimental: 15mg BD
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2013)
139
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2008)
150
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   France,   Hungary,   Italy,   Netherlands,   Poland,   Slovakia,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00615199
Other Study ID Numbers  ICMJE A3921043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP