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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 October 2017
Main ID:  NCT00746512
Date of registration: 03/09/2008
Prospective Registration: Yes
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)
Scientific 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
Date of first enrolment: September 2008
Target sample size: 45
Recruitment status: Completed
Study type:  Interventional
Study design:   
Phase:  Phase 1
Countries of recruitment
United Kingdom
Name:     Medical Monitor
Affiliation:  Merck Sharp & Dohme Corp.
Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: Placebo Over-Encapsulated Tablets
Drug: Placebo Tablets
Drug: Prednisone 15 mg
Drug: Prednisone 7.5 mg
Primary Outcome(s)
Synovial Blood Flow [Time Frame: Baseline and Day 14]
Secondary Outcome(s)
Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP]) [Time Frame: Baseline and Day 14]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available: Yes
Date Posted: 08/04/2011
Date Completed:
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