A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00787202
First received: November 6, 2008
Last updated: March 6, 2013
Last verified: March 2013
Results First Received: December 4, 2012  
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
Condition: Ulcerative Colitis
Interventions: Drug: CP- 690 550
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
CP-690,550 0.5 mg CP-690,550 tablets equivalent to CP-690,550 0.5 milligram (mg) orally twice daily for 8 weeks.
CP-690,550 3 mg CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
CP-690,550 10 mg CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
CP-690,550 15 mg CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.

Participant Flow:   Overall Study
    Placebo     CP-690,550 0.5 mg     CP-690,550 3 mg     CP-690,550 10 mg     CP-690,550 15 mg  
STARTED     49     31     33     33     49  
Treated     48     31     33     33     49  
COMPLETED     35     20     26     31     45  
NOT COMPLETED     14     11     7     2     4  
Adverse Event                 3                 2                 0                 0                 2  
Lack of Efficacy                 5                 6                 5                 2                 1  
Lost to Follow-up                 1                 0                 0                 0                 0  
Withdrawal by Subject                 2                 2                 2                 0                 0  
Protocol Violation                 2                 1                 0                 0                 1  
Randomized, not treated                 1                 0                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
CP-690,550 0.5 mg CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
CP-690,550 3 mg CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
CP-690,550 10 mg CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
CP-690,550 15 mg CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     CP-690,550 0.5 mg     CP-690,550 3 mg     CP-690,550 10 mg     CP-690,550 15 mg     Total  
Number of Participants  
[units: participants]
  49     31     33     33     49     195  
Age, Customized  
[units: participants]
           
18 to 44 years     28     16     18     17     31     110  
45 to 64 years     16     14     13     15     16     74  
Greater than or equal to (>=) 65 years     5     1     2     1     2     11  
Gender  
[units: participants]
           
Female     26     14     14     12     23     89  
Male     23     17     19     21     26     106  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Clinical Response   [ Time Frame: Week 8 ]

2.  Secondary:   Percentage of Participants With Clinical Remission   [ Time Frame: Week 8 ]

3.  Secondary:   Percentage of Participants With Endoscopic Response   [ Time Frame: Week 8 ]

4.  Secondary:   Percentage of Participants With Endoscopic Remission   [ Time Frame: Week 8 ]

5.  Secondary:   Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12   [ Time Frame: Baseline, Week 2, 4, 8, 12 ]

6.  Secondary:   Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8   [ Time Frame: Baseline, Week 8 ]

7.  Secondary:   Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8   [ Time Frame: Baseline, Week 4, 8 ]

8.  Secondary:   Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12   [ Time Frame: Baseline, Week 2, 4, 8, 12 ]

9.  Secondary:   Plasma Concentration of CP-690,550   [ Time Frame: 0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Pharmacokinetic (PK) parameters and their correlation with clinical response and inflammatory biomarkers were not reported as data from future studies were to be pooled for analysis.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00787202     History of Changes
Other Study ID Numbers: A3921063
Study First Received: November 6, 2008
Results First Received: December 4, 2012
Last Updated: March 6, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency