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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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00746512
First received: September 3, 2008
Last updated: May 14, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 3, 2008
Results First Received: December 17, 2010
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014