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

History of Changes

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
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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
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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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 ]

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2. Primary:

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

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3. Primary:

Cholesterol Ester Production Rate at Baseline [ Time Frame: Baseline ]

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4. Primary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
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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

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