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NCT Number: NCT00746512

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone 15 mg

Drug

Prednisone 15 mg tablets once daily for 15 days.

Other names: Prednisone

Placebo tablets

Drug

Prednisone placebo tablets once daily for 15 days.

Prednisone 7.5 mg

Drug

Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days

Other names: Prednisone

Placebo Over-Encapsulated Tablets

Drug

Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 4, 2008
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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