A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Comparator: Prednisone (Drug); Comparator: Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: compare the effect of prednisone vs placebo on synovial blood flow
Secondary outcome: compare the effect of prednisone vs placebo on disease activity as measured by DAS28(CRP)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Merck Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom; Recruiting
Paul Robinson, Phone: 44 1992 452396
Additional Information
Starting date: November 2008
Ending date: July 2009
Last updated: January 8, 2009
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