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

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00746512

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 I

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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by Merck:

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:	October 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746512

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00746512 History of Changes
Other Study ID Numbers:	MK-0000-088, 2008_531
Study First Received:	September 3, 2008
Results First Received:	December 17, 2010
Last Updated:	March 10, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

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

Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012