None listed
Conditions
Interventions
Daily administration for 2 weeks of 12.5 and 25 mg of MK-0966, orally, for 12 weeks and then daily administration of 50 mg orally for 40 weeks.
Group name:Placebo Type of group
placebo orally for 12 weeks
In Part I, after the discontinuation of NSAIDs, patients will be randomized to 12.5 mg daily of MK-0966 (N = 140), 25 mg daily of MK-0966 (N = 280), 500 mg daily of naproxen twice daily (N = 140) or placebo (N = 280) for 12 weeks. Paracetamol will be given to patients during the first 14 weeks of study treatment (until Visit 7.0) as rescue therapy for the advancement of pain
patients will continue in Part II and will continue in study therapy for an additional period of 40 weeks. Part II is a double-blind period, controlled by an active comparator whose purpose is to asse
the other half will continue with the daily dose of 25 mg of MK-0966. Patients who received naproxen in Part I will continue their same treatment in Part II.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a) The patient is ≥18 years old and does not present morbid obesity. b) Patients must demonstrate a level of serum P-HCG that matches a non-pregnant status at the pre-study visit and must agree to abstain, use oral contraceptives or use the simple barrier contraception method (the couple will use condoms or patient diaphragms, contraceptive sponges or the IUD) beginning at least 7 days before treatment and for at least 14 days after Visit 12.0 or a discontinuation visit. c) The patient must have satisfied at least four of the seven revised ARA criteria of 1987 for the diagnosis of rheumatoid arthritis. d) The diagnosis of rheumatoid arthritis must be made at least 6 months before the study begins and not before 16 years of age. e) Functional Class I, II or III of ARA. f) The overall evaluation of the disease activity by the patient (VAS of 100 mm) in the pre-study visit is less than 80 mm. g) There is a history of positive therapeutic benefit with NSAIDs. h) Patients have regularly taken an NSAID and at a therapeutic dose level for at least 30 days before enrolling in the study.
Exclusion criteria
Exclusion criteria: a) The patient is mentally or legally incapacitated, has significant emotional problems at the time of the study or has a history of psychosis. b) The patient suffers from a simultaneous medical / arthropathic disease that could confuse or interfere with the evaluation of efficacy including, without limitation: systemic lupus, spondylarthropathy, polymyalgia rheumatica, gout, pseudogout, psoriatic arthritis, Paget´s disease and ochronosis. c) The patient has a history of gastric, biliary, or small bowel surgery that causes poor malabsorption. d) The estimated creatinine clearance of the patient [Men: (140-age) x weight (kg) / (serum creatinine (mg /dL) x 72); Women: (0.85) (140-age) weight (kg)/ serum creatinine (mg / dL) x 72] is <30 ml/min or serum creatinine is greater than 2.0. e) The patient suffers from angina pectoris or congestive heart failure, with symptoms that occur during rest or minimal activity and / or has a history of myocardial infarction, coronary angioplasty or a coronary artery bypass was implanted during the last year. f) The patient suffers from uncontrolled hypertension [Note: patients with hypertension who are under medical control may participate (diastolic blood pressure <95, systolic blood pressure <165)]. g) The patient has a history of stroke or transient ischemic attack in the last 2 years. h) The patient has a history of hepatitis / liver disease that has been active in the past 2 years. i) The patient has been previously exposed to MK-0966 in a clinical study (patients who have been previously enrolled in a study of MK-0966 and who have been assigned to placebo treatment may participate in this study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Pressure sensitive joint count / Number of Pressure Sensitive Joints: 68 joints will be assessed to determine pain in response to pressure or passive movement . A pain score of the joint will be assigned with palpation or pain in passive movement (either is sufficient for a score of one or more) according to the scale described in the protocol. Measure:EFFECTIVENESS: • Count of pressure sensitive joints Timepoints:Visits 1.0 to 12.0 and the discontinuation visit (if the patient discontinues) ; Outcome name:Swollen joint count / Number of Swollen Joints: 66 joints will be evaluated to determine the presence of inflammation. Inflammation will be scored as follows: 0 = No inflammation, 1 = There is inflammation. Measure:Counting of swollen joints Timepoints:Visits 1.0 to 12.0 and in the discontinuation visit (if patients discontinue therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:a global assessment of pain by the patient on an Visual Analogue Scale (VAS) will be administered. Measure:Visual Analog Scale (VAS) Timepoints:Visits 1.0 to 12.0 and in the discontinuation visit ; Outcome name:the patient will rate his overall response to the study medication according to the scale described in the protocol Measure:Overall response to study medication Timepoints:Visits 3.0 to 12.0 and in the discontinuation visit ; Outcome name:the investigator will rate the therapeutic effect of the study medication using the scale of values described in the protocol. Measure:Overall response to therapy by the investigator Timepoints:Visits 3.0 to 12.0 and at the discontinuation visit ; Outcome name:if patients request to discontinue therapy, the reason for discontinuation will be recorded, for example, lack of efficacy, adverse events, etc. Measure:Discontinuation due to lack of efficacy Timepoints:in case patients decide to discontinue ; Outcome name:patients will respond to the disability scales indicated in the State of Health Evaluation Questionnaire (HAQ) of Stanford. Measure:Health Status Assessment Questionnaire (HAQ: disability scales) Timepoints:in Visits 1.0 to 12.0 and in the discontinuation visit ; Outcome name:patients will fill out the summary form 36 (SF-36). Measure:SF-36 Health Status Survey Timepoints:Visits 1.0, 2.0, 4.0, 6.0, 7.0, 8.0, 10.0 and 12.0 (and at the discontinuation visit) ; Outcome name:level of serum C-reactive protein Measure:Serum C-reactive protein levels Timepoints:Visits 1.0 to 12.0 (and in the discontinuation visit) ; Outcome name:The duration of this rigidity on the day of the examination will be determined by formulating the patients the questions described in the protocol. Measure:Duration of morning stiffness Timepoints:Visits 1.0 to 12.0 (and in the discontinuation visit) ; Outcome name:Vi | — |
Outcome results
None listed