A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)
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ClinicalTrials.gov Identifier: NCT00746512 |
Recruitment Status :
Completed
First Posted : September 4, 2008
Results First Posted : April 8, 2011
Last Update Posted : May 29, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: Prednisone 15 mg Drug: Placebo Tablets Drug: Prednisone 7.5 mg Drug: Placebo Over-Encapsulated Tablets | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | September 2008 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | September 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Prednisone 15 mg
Prednisone 15 mg tablets once daily for 15 days
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Drug: Prednisone 15 mg
Prednisone 15 mg tablets once daily for 15 days.
Other Name: Prednisone |
Placebo Comparator: Placebo 15 mg
Prednisone 15 mg placebo tablets once daily for 15 days
|
Drug: Placebo Tablets
Prednisone placebo tablets once daily for 15 days. |
Experimental: 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. |
Drug: Prednisone 7.5 mg
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
Other Name: Prednisone |
Placebo Comparator: Placebo 7.5 mg
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
Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days |
- Synovial Blood Flow [ Time Frame: 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.
- Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP]) [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746512
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00746512 |
Other Study ID Numbers: |
0000-088 2008_531 |
First Posted: | September 4, 2008 Key Record Dates |
Results First Posted: | April 8, 2011 |
Last Update Posted: | May 29, 2015 |
Last Verified: | May 2015 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Prednisone Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |