None listed
Conditions
Interventions
Etoricoxib 90 mg once a day will be administered.
Group name:Etoricoxib 90 mg Type of group
Etoricoxib 90 mg once a day will be administered.
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: a. The patient is a male or a woman at least 50 years old. b. The patient has a clinical diagnosis of rheumatoid arthritis (must have met at least 4 of 7 revised criteria of the 1987 ARA at some time in the past) and the investigator will require a chronic therapy with NSAIDs or a selective COX-2 inhibitor . c. The patient understands the study procedures and agrees to participate in the study, through written informed consent.
Exclusion criteria
Exclusion criteria: a. The patient has a functional Class IV diagnosis according to the American College of Rheumatology (ACR). b. The patient has a concurrent medical or rheumatic disease that could confuse or interfere with the evaluation of effectiveness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Global Assessment of the Condition of the Disease by the Patient Measure:Global Assessment of Disease by the patient at each study visit for each patient. Timepoints:1, 4, 8 and 12 months of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse events reported spontaneously, physical exams, vital signs (blood pressure and heart rate) and laboratory safety measurements (hematology and serum chemistry) and ECG. Measure:Gastrointestinal tolerability defined as the cumulative incidence of discontinuations due to clinical or laboratory gastrointestinal adverse events. Timepoints:1, 4, 8 and 12 months of therapy. | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed