A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)

Study Overview
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Brief Summary
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The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.

Official Title
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A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Prednisone 15 mg
* Drug: Placebo Tablets
* Drug: Prednisone 7.5 mg
* Drug: Placebo Over-Encapsulated Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is willing to limit alcohol intake to 3 or less beverages per day Patient agrees to use only acetaminophen/paracetamol for breakthrough pain Exclusion Criteria: Patient has other inflammatory arthritis (e.g. lupus). Patient has had major surgery or donated or lost 1 unit of blood in the last 4 weeks Patient has a history of drug or alcohol abuse in the last 2 years Patient has had a vaccine (with a live or attenuated virus) in the last two weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisone 15 mg<br>Prednisone 15 mg tablets once daily for 15 days | Drug: Prednisone 15 mg<br>* Prednisone 15 mg tablets once daily for 15 days.<br>* Other names: Prednisone;|
| Placebo Comparator: Placebo 15 mg<br>Prednisone 15 mg placebo tablets once daily for 15 days | Drug: Placebo Tablets<br>* Prednisone placebo tablets once daily for 15 days.<br>|
| Experimental: Prednisone 7.5 mg<br>Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. | Drug: Prednisone 7.5 mg<br>* Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days<br>* Other names: Prednisone;|
| Placebo Comparator: Placebo 7.5 mg<br>Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. | Drug: Placebo Over-Encapsulated Tablets<br>* Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Synovial Blood Flow | Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow. | Baseline and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP]) | The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) & swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale [VAS]), and the CRP (in mg/L measured from lab test). The scoring formula was: DAS28(CRP) = 0.56*SQR(TJC28) + 0.28*SQR(SJC28) + 0.36*ln(CRP+1) + 0.014*GH(VAS) + 0.96. Where SQR is square root and ln is natural log. The formula produces a score from 0 to 10: >5.1 means high disease activity; <3.2 means low disease activity, <2.6 is generally considered remission. | Baseline and Day 14 |