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

NCT ID: NCT01208181

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-27
• Study Completion Date: 2014-07-29

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) 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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Etoricoxib 60 mg/Etoricoxib 60 mg

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.

Group Type: EXPERIMENTAL

Etoricoxib 60 mg

Intervention Type: DRUG

One tablet orally once daily for 6 weeks.

Placebo to Etoricoxib 60 mg

Intervention Type: DRUG

One tablet orally once daily for 6 weeks.

Etoricoxib 60 mg/Etoricoxib 90 mg

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.

Group Type: EXPERIMENTAL

Etoricoxib 60 mg

Intervention Type: DRUG

One tablet orally once daily for 6 weeks.

Placebo to Etoricoxib 60 mg

Intervention Type: DRUG

One tablet orally once daily for 6 weeks.

Etoricoxib 90 mg

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.

Group Type: EXPERIMENTAL

Etoricoxib 90 mg

Intervention Type: DRUG

One tablet orally once daily for 6 weeks.

Placebo to Etoricoxib 90 mg

Intervention Type: DRUG

One tablet orally once daily for 6 weeks

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo to Etoricoxib 60 mg

Intervention Type: DRUG

One tablet orally once daily for 6 weeks.

Placebo to Etoricoxib 90 mg

Intervention Type: DRUG

One tablet orally once daily for 6 weeks

Interventions

Etoricoxib 60 mg

One tablet orally once daily for 6 weeks.

Intervention Type: DRUG

Etoricoxib 90 mg

One tablet orally once daily for 6 weeks.

Intervention Type: DRUG

Placebo to Etoricoxib 60 mg

One tablet orally once daily for 6 weeks.

Intervention Type: DRUG

Placebo to Etoricoxib 90 mg

One tablet orally once daily for 6 weeks

Intervention Type: DRUG

Other Intervention Names

MK-0663; MK-0663

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Bickham K, Kivitz AJ, Mehta A, Frontera N, Shah S, Stryszak P, Popmihajlov Z, Peloso PM. Evaluation of two doses of etoricoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), in the treatment of Rheumatoid Arthritis in a double-blind, randomized controlled trial. BMC Musculoskelet Disord. 2016 Aug 8;17:331. doi: 10.1186/s12891-016-1170-0.

Reference Type: RESULT

PMID: 27502582 (View on PubMed)

Other Identifiers

2010-019871-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0663-107

Identifier Type: -

Identifier Source: org_study_id