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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746512
• Other study ID #: 0000-088
• Secondary ID: 2008_531
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2008
• Last updated: May 7, 2015
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Prednisone 15 mg
Prednisone 15 mg tablets once daily for 15 days.
• Placebo Tablets
Prednisone placebo tablets once daily for 15 days.
• Prednisone 7.5 mg
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
• Placebo Over-Encapsulated Tablets
Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Synovial Blood Flow	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.	Baseline and Day 14	No
Secondary	Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])	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.	Baseline and Day 14	No