A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis - 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: Comparator: Prednisone Drug: Comparator: Placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

compare the effect of prednisone vs placebo on synovial blood flow [ Time Frame: over 2 to 15 days treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

compare the effect of prednisone vs placebo on disease activity as measured by DAS28(CRP) [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment:	36
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
1: Experimental Prednisone	Drug: Comparator: Prednisone Prednisone 15 mg tablets once daily for 15 days.
2: Placebo Comparator Placebo Comparator	Drug: Comparator: Placebo Prednisone placebo 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_531, 088
Study First Received:	September 3, 2008
Last Updated:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00746512 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid

Hormones, Hormone Substitutes, and Hormone Antagonists
Rheumatic Diseases
Glucocorticoids
Hormones
Pharmacologic Actions
Musculoskeletal Diseases
Therapeutic Uses
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on February 09, 2010