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Basic & Clinical Research
For Rheumatoid Arthritis
A Double-Blind, Placebo-Controlled Study of the Effect of MK-0966 on Blood and Synovial Fluid Prostaglandin Levels and Synovial Fluid MK-0966 concentration in Patients with Rheumatoid Arthritis
Objective:
1. To evaluate and compare the effects of MK-0966, diclofenac, and placebo on synovial fluid PGE-2 in patients with RA
2. To evaluate biochemical selectivity of MK-0966 in blood by comparing the effect of MK-0966, diclofenac, and placebo on LPS-stimulated whole blood PGE-2 and serum TXB-2
3. To evaluate and compare the effects of MK-0966, diclofenac, and placebo on synovial fluid TXB-2
4. To measure and compare MK-0966 concentration in synovial fluid versus plasma at steady state
Inclusion Criteria:
M/F OVER 18 YEARS OF AGE with dx. of RA for at least 6 months and not before age 16;WEIGHING NO MORE THAN 127 kg
May take NSAIDs but must d/c during a washout period (this includes ASA)
May take low-dose oral corticosteroids ( 10 mg per day of prednisone or equivalent) provided the patient has been taking the dose for the past 3 months and the dose has been stable for the previous 1 month
The patient must have a KNEE EFFUSION, which is a manifestation of the RA and not due to recent mechanical trauma. The knee effusion must be of sufficient volume to permit repeat aspiration of at least 3 ml. of synovial fluid.
Exclusion Criteria:
NO other concurrent inflammatory arthropathy that could confound or interfere with synovial fluid prostaglandin analysis
NO active sxs of gastritis or ulcer; NO past hx of gastric, small intestine or hepatobiliary surgery that has resulted in clinical malabsorption
NO serum creatinine greater than 2mg/dL.
NO uncontrolled HTN
NO hx of CAD with active angina or hx CHF
NO hx of hepatic disease/hepatitis that has been clinically active within the past 2 years
NO hx of leukemia, lymphoma, or myeloproliferative disease
NO intra-articular, intramuscular, or intravenous corticosteroids within 4 weeks;
NO intra-articular steroids to the effused knee within 3 months
NO ASA, ACETAMINOPHEN, NSAIDs, CYCLOSPORINE, SULFASALAZINE, MISOPROSTOL, WARFARIN AND TICLOPIDINE DURING THE ENTIRE STUDY PERIOD. IF TAKING ANY OF THESE MEDS, THEY WILL D/C 4 WEEKS PRIOR TO ENROLLMENT & CAN BE RESTARTED AFTER THE SECOND KNEE ASPIRATION
***PATIENTS WILL RECEIVE $250 PLUS TRANSPORTAION MONEY FOR PARTICIPATION***
Contact:
Eileen McCullagh, RN, CCRC
Voicemail: 212-598-6613
Beeper: (917) 218-5449
E-mail: Eileen.McCullagh@Med.NYU.Edu
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