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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.
  Purpose
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.

Condition Intervention 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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.



Enrollment: 45
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prednisone 15 mg
Prednisone 15 mg tablets once daily for 15 days
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00746512     History of Changes
Other Study ID Numbers: 0000-088
2008_531
First Submitted: September 3, 2008
First Posted: September 4, 2008
Results First Submitted: December 17, 2010
Results First Posted: April 8, 2011
Last Update Posted: May 29, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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


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