Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01059864
First received: January 28, 2010
Last updated: November 14, 2012
Last verified: November 2012
Results First Received: November 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: CP-690,550
Drug: Atorvastatin
Drug: Atorvastatin 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CP-690,550 Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
CP-690,550 + Atorvastatin Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
CP-690,550 + Placebo Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.

Participant Flow for 2 periods

Period 1:   Open-Label Run-In Phase
    CP-690,550     CP-690,550 + Atorvastatin     CP-690,550 + Placebo  
STARTED     111     0     0  
COMPLETED     98     0     0  
NOT COMPLETED     13     0     0  
Adverse Event                 7                 0                 0  
Lack of Efficacy                 1                 0                 0  
Lost to Follow-up                 2                 0                 0  
Withdrawal by Subject                 1                 0                 0  
Protocol Violation                 2                 0                 0  

Period 2:   Double-Blind Treatment Phase
    CP-690,550     CP-690,550 + Atorvastatin     CP-690,550 + Placebo  
STARTED     0     50     48  
Treated     0     50     47  
COMPLETED     0     47     45  
NOT COMPLETED     0     3     3  
Adverse Event                 0                 3                 3  



  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.
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Reporting Groups
  Description
CP-690,550 Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.

Baseline Measures
    CP-690,550  
Number of Participants  
[units: participants]
  111  
Age  
[units: years]
Mean ± Standard Deviation
  52.3  ± 11.5  
Gender  
[units: participants]
 
Female     99  
Male     12  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12   [ Time Frame: Baseline (Week 6), Week 12 ]

2.  Secondary:   Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12   [ Time Frame: Baseline (Week 6), Week 12 ]

3.  Secondary:   12-Hours Fasting Lipid Profile   [ Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12 ]

4.  Secondary:   12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins   [ Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12 ]

5.  Secondary:   12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles   [ Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12 ]

6.  Secondary:   12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles   [ Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12 ]

7.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])   [ Time Frame: Day 0, Week 6 (Baseline), 12 ]

8.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])   [ Time Frame: Day 0, Week 6 (Baseline), 12 ]

9.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])   [ Time Frame: Day 0, Week 6 (Baseline), 12 ]

10.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])   [ Time Frame: Day 0, Week 6 (Baseline), 12 ]

11.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response   [ Time Frame: Week 6 (Baseline), 12 ]

12.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response   [ Time Frame: Week 6 (Baseline), 12 ]

13.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response   [ Time Frame: Week 6 (Baseline), 12 ]

14.  Secondary:   Tender-Joint Count   [ Time Frame: Day 0, Week 6 (Baseline), 12 ]

15.  Secondary:   Swollen-Joint Count   [ Time Frame: Day 0, Week 6 (Baseline), Week 12 ]

16.  Secondary:   C-Reactive Protein (CRP)   [ Time Frame: Day 0, Week 6 (Baseline), 12 ]

17.  Secondary:   Erythrocyte Sedimentation Rate (ESR)   [ Time Frame: Day 0, Week 6 (Baseline), 12 ]

18.  Secondary:   Patient Assessment of Arthritis Pain   [ Time Frame: Day 0, Week 6 (Baseline), 12 ]

19.  Secondary:   Physician's Global Assessment (PhysGA) of Arthritis Pain   [ Time Frame: Day 0, Week 6 (Baseline), Week 12 ]

20.  Secondary:   Patient's Global Assessment (PtGA) of Arthritis Pain   [ Time Frame: Day 0, Week 6 (Baseline), Week 12 ]

21.  Secondary:   Health Assessment Questionnaire Disability Index (HAQ-DI)   [ Time Frame: Day 0, Week 6 (Baseline), 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
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  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: NCT01059864     History of Changes
Other Study ID Numbers: A3921109
Study First Received: January 28, 2010
Results First Received: November 14, 2012
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration