Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)
Phase 2
Completed
- Conditions
- Arthritis, Rheumatoid
- Registration Number
- NCT00542022
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
Inclusion Criteria
- Patient has had diagnosis of RA made at least 6 months prior to study start and was greater than 16 years of age when diagnosed
- Patient has active RA with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints
- Excepting rheumatoid arthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests
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Exclusion Criteria
- Patient is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis
- Patient has a history of any clinically significant disease of the cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or uncontrolled blood pressure
- Female patient is pregnant or breast-feeding
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method MK0812 once daily for 12 weeks will demonstrate clinical effectiveness superior to placebo for treatment of Arthritis, as assessed by changes from baseline in the patient's swollen joint count 12 weeks
- Secondary Outcome Measures
Name Time Method MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients 12 weeks