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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Prednisone 7.5 mg; Drug: Placebo Tablets; Drug: Prednisone 15 mg; Drug: Placebo Over-Encapsulated Tablets

• Registration Number: NCT00746512
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-03
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-12-17
• Results First Submitted QC: 2011-03-10
• Results First Posted: 2011-04-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone 7.5 mg	Prednisone 7.5 mg	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.
Placebo 15 mg	Placebo Tablets	Prednisone 15 mg placebo tablets once daily for 15 days
Prednisone 15 mg	Prednisone 15 mg	Prednisone 15 mg tablets once daily for 15 days
Placebo 7.5 mg	Placebo Over-Encapsulated Tablets	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.

Primary Outcome Measures

Name	Time	Method
Synovial Blood Flow	Baseline and Day 14	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.

Secondary Outcome Measures

Name	Time	Method
Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])	Baseline and Day 14	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.