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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT01208181
• Date of registration: 22/09/2010
• Prospective Registration: Yes
• Primary sponsor: Organon and Co
• Public title: A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
• Scientific title: 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
• Date of first enrolment: September 27, 2010
• Target sample size: 1404
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01208181
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Canada, Colombia, Czech Republic, Finland, Germany, Guatemala, India, Lithuania, Mexico, Panama, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Taiwan, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Placebo to Etoricoxib 60 mg

Drug: Etoricoxib 90 mg

Drug: Placebo to Etoricoxib 90 mg

Drug: Etoricoxib 60 mg

Primary Outcome(s)

Percentage of Participants Who Discontinued Study Drug Due to an AE [Time Frame: Up to Week 12]

Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo) [Time Frame: Baseline and Week 6]

Percentage of Participants Who Experienced at Least One Adverse Event (AE) [Time Frame: Up to 112 days]

Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo) [Time Frame: Baseline and Week 6]

Secondary Outcome(s)

Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1 [Time Frame: Week 6 and Week 10 to Week 12]

Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg) [Time Frame: Baseline and Week 6]

Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg) [Time Frame: Baseline and Week 6]

Secondary ID(s)

2010-019871-31

0663-107

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/05/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01208181