AN ACTIVE-COMPARATOR-AND PLACEBO-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND, 52-WEEKSTUDY TO ASSESS THE SAFETY AND EFFICACY OF MK-0663 IN RHEUMATOID ARTHRITIS PATIENTS

MERCK SHARP & DOHME PERÚ S.R.L.,0 个研究点目标入组 0 人开始时间: 1999年10月29日最近更新: 2023年9月4日

试验速览

暂无简介。

•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.

•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.

发起方

MERCK SHARP & DOHME PERÚ S.R.L.,