A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etoricoxib 60 mg; Etoricoxib 90 mg; Placebo to Etoricoxib 60 mg; Placebo to Etoricoxib 90 mg
Intervention description: One tablet orally once daily for 6 weeks.; One tablet orally once daily for 6 weeks.; One tablet orally once daily for 6 weeks.; One tablet orally once daily for 6 weeks
Intervention MeSH terms: Etoricoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1404.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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