A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Rheumatoid Arthritis

0663-107

This is a 2-part (6 weeks duration for each part), randomized, double-blind, placebo-controlled study in participants with rheumatoid arthritis. The hypothesis is that etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to placebo after 6 weeks of treatment, as measured by the greater mean improvement from baseline in the Disease Activity Score C-Reactive Protein (DAS-28 CRP), and by the greater mean improvement in Patient Global Assessment of Pain (PGAP) from baseline over 6 weeks of treatment. Additionally, the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study.

2010-09-27

2014-06-09

2014-07-29

Completed

Early phase I

1404

Inclusion Criteria: * Is male or female ≥ 18 years of age in general good health (other than RA) * Has an American College of Rheumatology Rheumatoid Clinical Response Criteria (ACR) Functional Class I, II, or III * Has a diagnosis of RA at least 6 months ago and was at least 16 years of age when diagnosed * Has a history of positive therapeutic benefit with nonsteroidal anti-inflammatory drugs (NSAIDs) and is taking an NSAID on a regular basis and at a therapeutic dose level and is not anticipated to undergo a change during the study Exclusion Criteria: * Has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy * Has a history of gastric or biliary surgery (including gastric bypass surgery) or small intestine surgery that causes clinical malabsorption * Has an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease * Has a confirmed medical diagnosis of ischemic heart disease, cerebrovascular disease, or peripheral artery occlusive disease * Class II-IV congestive heart failure * Has uncontrolled hypertension (systolic \>160 mm Hg or diastolic \> 90 mm Hg) at Visit 1 or Visit 2 * Has a clinical diagnosis of hepatic insufficiency defined as Child-Pugh score ≥5 * Has estimated glomerular filtration rate ≤30 mL/min * Has a history of neoplastic disease within 5 years (exceptions: basal cell carcinoma or carcinoma in situ of the cervix) * Is allergic to etoricoxib; history of a significant clinical or laboratory adverse experience associated with etoricoxib; hypersensitivity to aspirin or NSAIDs; or allergy to acetaminophen/paracetamol * Has a personal or family history of an inherited or acquired bleeding disorder * Requires oral corticosteroid therapy in excess of the equivalent of 10 mg daily of prednisone and/or have not been on a stable dose for at least 4 weeks prior to Visit 1 and/or whose dose is not expected to remain stable during the study * Treated with B-cell depleting therapies within the past 6 months or anticipate this treatment during this trial * Is a recreational or illicit drug use, or history within 5 years of drug or alcohol abuse/dependence; * Is morbidly obese (defined as body mass index ≥40 kg/m\^2) * Is pregnant or breast feeding

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2024-05-23