A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01484561
First received: November 30, 2011
Last updated: March 4, 2014
Last verified: March 2014
Results First Received: January 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Arthritis, Rheumatoid
Interventions: Drug: CP-690,550 or Placebo
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
CP-690,550/Placebo Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
Placebo/Placebo Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)

Participant Flow:   Overall Study
    CP-690,550/Placebo     Placebo/Placebo  
STARTED     97     51  
COMPLETED     88     45  
NOT COMPLETED     9     6  
Lack of Efficacy                 3                 1  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 3                 0  
Not specified                 1                 1  
Adverse Event                 1                 4  



  Baseline Characteristics
  Hide Baseline Characteristics

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
CP-690,550/Placebo Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
Placebo/Placebo Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Total Total of all reporting groups

Baseline Measures
    CP-690,550/Placebo     Placebo/Placebo     Total  
Number of Participants  
[units: participants]
  97     51     148  
Age  
[units: years]
Mean ± Standard Deviation
  51.9  ± 12.7     47.3  ± 11.8     50.3  ± 12.6  
Gender  
[units: participants]
     
Female     75     36     111  
Male     22     15     37  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

2.  Secondary:   Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

3.  Secondary:   Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]

4.  Secondary:   Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

5.  Secondary:   Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

6.  Secondary:   Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]

7.  Secondary:   Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

8.  Secondary:   Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

9.  Secondary:   Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]

10.  Secondary:   Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

11.  Secondary:   Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

12.  Secondary:   Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]

13.  Secondary:   Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response   [ Time Frame: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2 ]

14.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response   [ Time Frame: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2 ]

15.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response   [ Time Frame: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2 ]

16.  Secondary:   Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

17.  Secondary:   LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

18.  Secondary:   LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]

19.  Secondary:   LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

20.  Secondary:   LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

21.  Secondary:   LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]

22.  Secondary:   LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

23.  Secondary:   LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

24.  Secondary:   LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]

25.  Secondary:   LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

26.  Secondary:   LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

27.  Secondary:   LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]

28.  Secondary:   LS Mean Change at End of Period 1 From Baseline in CRP   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

29.  Secondary:   LS Mean Change at End of Period 2 From Baseline in CRP   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

30.  Secondary:   LS Mean Change at End of Period 2 From End of Period 1 in CRP   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]

31.  Secondary:   LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

32.  Secondary:   LS Mean Change at End of Period 2 From Baseline in PGAA   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

33.  Secondary:   LS Mean Change at End of Period 2 From End of Period 1 in PGAA   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]

34.  Secondary:   LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

35.  Secondary:   LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

36.  Secondary:   LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis   [ Time Frame: Day 43 of Period 1, Day 29 of Period 1 ]

37.  Secondary:   LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

38.  Secondary:   LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

39.  Secondary:   LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain   [ Time Frame: Day 43 of Period 2, Day 29 of Period 2 ]

40.  Secondary:   LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score   [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]

41.  Secondary:   LS Mean Change at End of Period 2 From Baseline HAQ-DI Score   [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]

42.  Secondary:   LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score   [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: NCT01484561     History of Changes
Other Study ID Numbers: A3921152
Study First Received: November 30, 2011
Results First Received: January 11, 2014
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration