Status:
COMPLETED
A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
Lead Sponsor:
Organon and Co
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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) adm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2014
Estimated Enrollment :
1404 Patients enrolled
Trial Details
Trial ID
NCT01208181
Start Date
September 27 2010
End Date
July 29 2014
Last Update
June 18 2024
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