Back to resultsA Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Prednisone 15 mg
Placebo Tablets
Prednisone 7.5 mg
Placebo Over-Encapsulated Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Prednisone 15 mg
Placebo 15 mg
Prednisone 7.5 mg
Placebo 7.5 mg
Arm Description
Prednisone 15 mg tablets once daily for 15 days
Prednisone 15 mg placebo tablets once daily for 15 days
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00746512
Brief Title
A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisone 15 mg
Arm Type
Experimental
Arm Description
Prednisone 15 mg tablets once daily for 15 days
Arm Title
Placebo 15 mg
Arm Type
Placebo Comparator
Arm Description
Prednisone 15 mg placebo tablets once daily for 15 days
Arm Title
Prednisone 7.5 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo 7.5 mg
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisone 15 mg
Other Intervention Name(s)
Prednisone
Intervention Description
Prednisone 15 mg tablets once daily for 15 days.
Intervention Type
Drug
Intervention Name(s)
Placebo Tablets
Intervention Description
Prednisone placebo tablets once daily for 15 days.
Intervention Type
Drug
Intervention Name(s)
Prednisone 7.5 mg
Other Intervention Name(s)
Prednisone
Intervention Description
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
Intervention Type
Drug
Intervention Name(s)
Placebo Over-Encapsulated Tablets
Intervention Description
Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
Primary Outcome Measure Information:
Title
Synovial Blood Flow
Description
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.
Time Frame
Baseline and Day 14
Secondary Outcome Measure Information:
Title
Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])
Description
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.
Time Frame
Baseline and Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
22972032
Citation
Seymour MW, Kelly S, Beals CR, Malice MP, Bolognese JA, Dardzinski BJ, Cheng AS, Cummings CE, Smugar SS, McClinton C, Fox A, Dooley WM, Pitzalis C, Taylor PC. Ultrasound of metacarpophalangeal joints is a sensitive and reliable endpoint for drug therapies in rheumatoid arthritis: results of a randomized, two-center placebo-controlled study. Arthritis Res Ther. 2012 Sep 12;14(5):R198. doi: 10.1186/ar4034.
Results Reference
result
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A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)
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