A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)

• Status: Completed
• Trial end date: 2014-07-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Etoricoxib

Criteria

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