Arthritis, Rheumatoid
Conditions
Brief summary
To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.
Interventions
DRUGMK0812 / Duration of Treatment: 12 Weeks
DRUGComparator: placebo (unspecified) / Duration of Treatment: 12 Weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients | 12 weeks |
Outcome results
None listed