Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01262118
First received: November 15, 2010
Last updated: December 17, 2012
Last verified: December 2012
Results First Received: December 17, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Rheumatoid Arthritis
Intervention: Drug: CP-690,550 (tasocitinib)

  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
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Reporting Groups
  Description
Rheumatoid Arthritis Cohort Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
Healthy Volunteers Cohort Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.

Participant Flow for 2 periods

Period 1:   Baseline Assessment Period (3 Days)
    Rheumatoid Arthritis Cohort     Healthy Volunteers Cohort  
STARTED     36     33  
COMPLETED     36     33  
NOT COMPLETED     0     0  

Period 2:   Treatment Period (6 Weeks)
    Rheumatoid Arthritis Cohort     Healthy Volunteers Cohort  
STARTED     36     0  
COMPLETED     36     0  
NOT COMPLETED     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.
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Reporting Groups
  Description
Rheumatoid Arthritis Cohort Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
Healthy Volunteers Cohort Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
Total Total of all reporting groups

Baseline Measures
    Rheumatoid Arthritis Cohort     Healthy Volunteers Cohort     Total  
Number of Participants  
[units: participants]
  36     33     69  
Age, Customized  
[units: participants]
     
18 to 44 years     9     7     16  
45 to 64 years     25     25     50  
Greater than or equal to (>=) 65 years     2     1     3  
Gender  
[units: participants]
     
Female     30     28     58  
Male     6     5     11  



  Outcome Measures
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1.  Primary:   High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline   [ Time Frame: Baseline ]

2.  Primary:   High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6   [ Time Frame: Week 6 ]

3.  Primary:   Cholesterol Ester Production Rate at Baseline   [ Time Frame: Baseline ]

4.  Primary:   Cholesterol Ester Production Rate at Week 6   [ Time Frame: Week 6 ]

5.  Secondary:   Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration   [ Time Frame: Baseline, Week 6 ]

6.  Secondary:   Cholesterol Ester Fractional Catabolic Rate   [ Time Frame: Baseline, Week 6 ]

7.  Secondary:   Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate   [ Time Frame: Baseline, Week 6 ]

8.  Secondary:   Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate   [ Time Frame: Baseline, Week 6 ]

9.  Secondary:   High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate   [ Time Frame: Baseline, Week 6 ]

10.  Secondary:   High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate   [ Time Frame: Baseline, Week 6 ]

11.  Secondary:   Cholesterol Efflux Rate   [ Time Frame: Baseline, Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


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: NCT01262118     History of Changes
Other Study ID Numbers: A3921130
Study First Received: November 15, 2010
Results First Received: December 17, 2012
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration