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

Phase 3

Completed

• Conditions: Health Condition 1: null- Rheumatoid ArthritisHealth Condition 2: M069- Rheumatoid arthritis, unspecified

• Registration Number: CTRI/2011/07/001926
• Lead Sponsor: Merck Sharp and Dohme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1776

Inclusion Criteria

There is no maximum age for this study.

Is in general good health (other than RA);

Has an 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

Exclusion Criteria

There is no maximum age for this study.

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;

Has active gastric ulcer or history of inflammatory bowel disease;

Had undergone coronary artery bypass graft surgery (CABG), angioplasty, or had a cerebrovascular accident or transient ischemic attack within the past 6 months or has active ischemic heart disease, cerebrovascular disease, or peripheral vascular disease;

Class II-IV congestive heart failure;

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;

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 greater than or equal to 40 kg/m2);

Is pregnant or breast feeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified