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A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

This study has been terminated.
(See Detailed Description field)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00424294
First received: January 18, 2007
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: September 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: CP-195,543
Drug: celecoxib
Drug: Methotrexate

  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 and Celecoxib Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
CP-195543 and Celecoxib CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.

Participant Flow:   Overall Study
    Placebo and Celecoxib     CP-195543 and Celecoxib  
STARTED     36     34  
Treated     35     34  
COMPLETED     28     19  
NOT COMPLETED     8     15  
Adverse Event                 4                 10  
Lack of Efficacy                 2                 1  
Withdrawal by Subject                 1                 2  
Unspecified                 0                 2  
Randomized but not Treated                 1                 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.
Full analysis set (FAS) was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.

Reporting Groups
  Description
Placebo and Celecoxib Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
CP-195543 and Celecoxib CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
Total Total of all reporting groups

Baseline Measures
    Placebo and Celecoxib     CP-195543 and Celecoxib     Total  
Number of Participants  
[units: participants]
  35     34     69  
Age  
[units: years]
Mean ± Standard Deviation
  54.1  ± 11.6     57.7  ± 12.7     55.9  ± 12.2  
Gender  
[units: participants]
     
Female     33     27     60  
Male     2     7     9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8   [ Time Frame: Week 1, 2, 4, 8 ]

3.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response   [ Time Frame: Week 1, 2, 4, 8, 12 ]

4.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response   [ Time Frame: Week 1, 2, 4, 8, 12 ]

5.  Secondary:   Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

6.  Secondary:   Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

7.  Secondary:   Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

8.  Secondary:   Change From Baseline in Patient’s Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

9.  Secondary:   Change From Baseline in Physician’s Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

10.  Secondary:   Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

11.  Secondary:   Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

12.  Secondary:   Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

13.  Secondary:   Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

14.  Secondary:   Number of Participants Who Withdrew From Study Due to Lack of Efficacy   [ Time Frame: Baseline up to Week 12 ]

15.  Secondary:   Time to Withdrawal Due to Lack of Efficacy   [ Time Frame: Baseline up to Week 12 ]

16.  Secondary:   Number of Participants With Clinical Laboratory Abnormalities   [ Time Frame: Baseline up to Week 13 ]

17.  Other Pre-specified:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 28 days after last dose ]

18.  Other Pre-specified:   Number of Adverse Events by Severity   [ Time Frame: Baseline up to 28 days after last dose ]

19.  Other Pre-specified:   Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91   [ Time Frame: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91 ]

20.  Other Pre-specified:   Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91   [ Time Frame: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91 ]

21.  Other Pre-specified:   Number of Participants With Abnormal Electrocardiogram (ECG)   [ Time Frame: Baseline up to Week 12 ]

22.  Other Pre-specified:   Number of Participants With Categorical Vital Signs Data   [ Time Frame: Baseline, Week 12 ]


  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
The study was terminated early because it was determined that the dual therapy with CP-195543 and celecoxib had poor tolerability and a high discontinuation rate.


  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


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00424294     History of Changes
Other Study ID Numbers: A7701005
Study First Received: January 18, 2007
Results First Received: September 10, 2014
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration