None listed
Conditions
Interventions
MK-0663 90 mg Type of group
MK-0663 90 mg daily, tablet, orally for 52 weeks
Group name:Naproxen Type of group
Naproxen 500mg, twice daily, tablet, orally for 52 weeks
Sponsors
MERCK SHARP & DOHME PERÚ S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient is >18 years of age and not considered morbidly obese. 2. Female patient must demonstrate a serum P-HCG level consistent with a non-gravid state at Visit 1.0 and agree to remain abstinent or use double-barrier contraception (partner using condom and patient using diaphragm, contraceptive sponge, spermicide, or lUD) beginning at least 7 days prior to Visit 2.0 and continuing at least 14 days after Visit 11.0 or a discontinuation visit. Women who are postmenopausal or status post hysterectomy or tubal ligation are exempt from this requirement. 3. Patient must have satisfied (for RA diagnosis) at least 4 of 7 ARA 1987 revised criteria for the diagnosis of RA sometime in the past. 4. Patient has diagnosis of RA made at least 6 months prior to study start and no earlier than 16 years of age. 5. Patient is ARA functional Class I, II, or III. 6. Patient´s global assessment of disease activity (VAS of 100 mm) at the prestudy visit is less than 80 mm. 7. Patient has a history of positive therapeutic benefit with NSAIDs. 8. Patient has taken an NSAID on a regular basis and at a therapeutic dose level for at least 30 days prior to study enrollment. 9. Antirheumatic therapy outside of the study medication and patient´s approved was administered in a stable manner during the required time periods indicated in the protocol, and it is anticipated that it will not undergo any changes during the first 3 months (until Visit 6.0) of the protocol.
Exclusion criteria
Exclusion criteria: 1. Patient is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis. 2. Patient has a concurrent medical/arthropathic disease that could confound or interfere with evaluation of efficacy. 3. Patient has a history of gastric, biliary, or small intestine surgery that causes clinical malabsorption. 4. Patient´s estimated creatinine clearance is <30 mL/min or serum creatinine is greater than 2.0 mg/dL. 5. Patient has angina or congestive heart failure, with symptoms that occur at rest or minimal activity, and/or has a history within the past 1 year of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting. 6. Patient has uncontrolled hypertension. 7. Patient has a history of stroke or transient ischemic attack within the past 2 years. 8. Patient has a history of hepatitis/hepatic disease that has been active within the previous 2 years. 9. Patient has a history of neoplastic disease and does not meet one of the exceptions listed in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:68 joints will be assessed to determine pain in response to pressure or passive movement in Visits 1.0 to 11.0 and the discontinuation visit, the comparison being the mean change from baseline over the treatment period of 12 weeks Measure:Pressure sensitive joint count / Number of Pressure Sensitive Joints Timepoints:Comparison after 2, 4, 8, and 12 weeks of the study therapy (and at the time of discontinuation, if applicable). ; Outcome name:At Visits 1.0 through 11.0 and at the discontinuation visit (if patient discontinúes), 66 joints will be assessed for the presence of swelling, the comparison being the mean change from baseline over the treatment period of 12 weeks Measure:SwoIIen Joint Count/Number of Swollen Joints Timepoints:Comparison after 2, 4, 8, and 12 weeks of the study therapy (and at the time of discontinuation, if applicable). ; Outcome name:A patient overall assessment of pain on a Visual Analog Scale (VAS) will be administered at Visits 1.0 through 11.0, and at the discontinuation visit (if patient discontinúes), the comparison being the mean change from baseline over the treatment period of 12 weeks Measure:Patient´s Global Assessment of Pain (VAS) Timepoints:Comparison after 2, 4, 8, and 12 weeks of the study therapy (and at the time of discontinuation, if applicable). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Patients will respond to the Stanford Health Assessment Questionnaire (HAQ) disability scales at Visits 1.0 through 11.0 (and discontinuation) the comparison being changes from baseline. Measure:Health Assessment. Questionnaire (HAQ: disability scales) Timepoints:Comparison after 2, 4, 8, and 12 weeks of the study therapy (and at the time of discontinuation, if applicable). ; Outcome name:proportion of patients, in each treatment group, meeting the American College of Rheumatology 20% responder criteria [ACR20], and the proportion of patients in each treatment group completing Part I and meeting ACR20 response criteria, the comparison being changes from baseline. Measure:ACR20 response rate Timepoints:Comparison after 2, 4, 8, and 12 weeks of the study therapy (and at the time of discontinuation, if applicable). ; Outcome name:Blood will be obtained for determination of serum C-reactive protein level. Measure:C-Reactive Protein Timepoints:Visits 1.0 through 11.0 (and discontinuation visit) | — |
Contacts
Public ContactStela López
MERCK SHARP & DOHME PERÚ S.R.L
Outcome results
None listed