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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00746512
First Posted: September 4, 2008
Last Update Posted: May 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
September 3, 2008
September 4, 2008
December 17, 2010
April 8, 2011
May 29, 2015
September 2008
September 2009   (Final data collection date for primary outcome measure)
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.
compare the effect of prednisone vs placebo on synovial blood flow [ Time Frame: over 2 to 15 days treatment ]
Complete list of historical versions of study NCT00746512 on ClinicalTrials.gov Archive Site
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.

compare the effect of prednisone vs placebo on disease activity as measured by DAS28(CRP) [ Time Frame: 15 days ]
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A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Prednisone 15 mg
    Prednisone 15 mg tablets once daily for 15 days.
    Other Name: Prednisone
  • Drug: Placebo Tablets
    Prednisone placebo tablets once daily for 15 days.
  • Drug: Prednisone 7.5 mg
    Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
    Other Name: Prednisone
  • Drug: Placebo Over-Encapsulated Tablets
    Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
  • Experimental: Prednisone 15 mg
    Prednisone 15 mg tablets once daily for 15 days
    Intervention: Drug: Prednisone 15 mg
  • Placebo Comparator: Placebo 15 mg
    Prednisone 15 mg placebo tablets once daily for 15 days
    Intervention: Drug: Placebo Tablets
  • 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.

    Intervention: Drug: Prednisone 7.5 mg
  • 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.

    Intervention: Drug: Placebo Over-Encapsulated Tablets
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
September 2009
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United Kingdom
 
NCT00746512
0000-088
2008_531
Not Provided
Not Provided
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP