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

History of Changes

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 + Atorvastatin	CP-690,550 + Placebo
STARTED	50	48
Treated	50	47
COMPLETED	47	45
NOT COMPLETED	3	3
Adverse Event	3	3

Baseline Characteristics

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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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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16. Secondary:

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

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17. Secondary:

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

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18. Secondary:

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

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19. Secondary:

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

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20. Secondary:

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

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21. Secondary:

Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Day 0, Week 6 (Baseline), 12 ]

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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:	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

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