MK-0663/Etoricoxib in Patients With Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A Phase III, Two-Part, Randomised, Double-Blind, Placebo-Controlled, Multicentre Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK 0663/Etoricoxib in Patients With Rheumatoid Arthritis

• IRAS ID

  58275

• Contact name

  Emmanuel George

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2010-019871-31

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Rheumatoid arthritis (RA) is a chronic, inflammatory disorder that may affect many tissues and organs, but principally attacks synovial joints - a common joint in the body such as the knee or wrist. About 1% of the world's population is affected by rheumatoid arthritis. It can be a disabling and painful condition, which can lead to substantial loss of functioning and mobility. The primary aim in the treatment of RA patients is to alleviate the current symptoms and modify the disease process. Analgesic medication (painkillers) and anti-inflammatory drugs (NSAIDs) are often used to suppress the symptoms, while disease-modifying antirheumatic drugs (DMARDs) are often required to inhibit or halt the underlying immune process and prevent long-term damage. NSAIDs (such as aspirin and ibuprofen) are the primary therapy for many RA patients suffering from daily pain. However, the adverse effects of NSAIDs have become increasingly prevalent, being often related to direct and indirect irritation of the gastrointestinal (GI) tract. Etoricoxib is a drug which has shown to provide effectiveness in patients suffering from RA and other inflammatory diseases, but with less of an effect on the GI tract. This 2-part trial is to further assess the efficacy of etoricoxib in doses of 60 and 90 mg in patients with RA. The placebo (inactive substance, sometimes known as a sugar pill) controlled Part I assesses the efficacy and tolerability of etoricoxib 60 mg and 90 mg. Part II is to evaluate if it is beneficial to either remain on the 60 mg dose or to increase the dose from 60 mg to 90 mg. This is a randomised, double-blind, placebo-controlled trial meaning neither the investigator nor the patient knows which medication (test drug or placebo) is being given. This multicentre clinical trial, sponsored by Merck & Co., Inc. will take place in several countries worldwide. It is anticipated that approximately 1776 patients will be recruited worldwide.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  10/H0308/87

• Date of REC Opinion

  1 Dec 2010

• REC opinion

  Further Information Favourable Opinion