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

Organon

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Etoricoxib 90 mg; Drug: Etoricoxib 60 mg; Drug: Placebo to Etoricoxib 60 mg; Drug: Placebo to Etoricoxib 90 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01208181

0663-107

2010-019871-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,404 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,404 participants in 4 patient groups, including a placebo group

Etoricoxib 60 mg/Etoricoxib 60 mg

Experimental group

Description:

The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and Part 2 of the study.

Treatment:

Drug: Placebo to Etoricoxib 60 mg

Drug: Etoricoxib 60 mg

Etoricoxib 60 mg/Etoricoxib 90 mg

Experimental group

Description:

The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 2 of the study.

Treatment:

Drug: Placebo to Etoricoxib 60 mg

Drug: Etoricoxib 60 mg

Etoricoxib 90 mg

Experimental group

Description:

The etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study.

Treatment:

Drug: Placebo to Etoricoxib 90 mg

Drug: Etoricoxib 90 mg

Placebo

Placebo Comparator group

Description:

The placebo treatment sequence will receive matching placebo to etoricoxib tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study.

Treatment:

Drug: Placebo to Etoricoxib 90 mg

Drug: Placebo to Etoricoxib 60 mg