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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Atorvastatin Placebo; Drug: Atorvastatin; Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01059864

A3921109

Details and patient eligibility

About

All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first measure the effects of CP-690,550 on cholesterol levels and then the effects of adding atorvastatin on those levels.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must be diagnosed as having active rheumatoid arthritis
• agree to participate in the study and sign and informed consent document

Exclusion criteria

• History of serious infection within the past 6 months
• test positive for TB
• have any uncontrolled clinically significant disease or laboratory tests
• require administration of prohibited medications during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Atorvastatin

Drug: CP-690,550

Drug: CP-690,550

Arm 2

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: Atorvastatin Placebo