Official Title: “A Multi-Center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis”

A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily

Study Type: Interventional

Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: Meloxicam

INCLUSION CRITERIA:

• Age greater than or equal to 18 and less than or equal to 80
• Diagnosis of Rheumatoid Arthritis for at least six weeks
• Taking an NSAID
• If female: using adequate contraception
• Willingness to stop current NSAID until criteria reached to begin study drug
• Able to provide written informed consent

EXCLUSION CRITERIA:

• Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug
• Pregnancy, lactating
• Use of investigational drug within 30 days prior to entering the trial
• History of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding
• History of cerebrovascular or other bleeding disorder
• Severe hypertension
• Other disease that might interfere with safety of the patient or evaluation of trial drug (investigator's opinion)
• RA of functional class IV
• Synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial
• Concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic GI-medication, analgesic drug (except acetaminophen up to 4 grams/day)
• DMARDs initiated within past three months or dose changed less than two months before entering the trial.
• Therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial
• Concomitant therapy with ACTH within past month before entering the trial.
• History of narcotic or alcohol abuse (past 12 months)
• Abnormal laboratory values
• Previous participation in the present trial

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Ltd./Bracknell  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00042068

Study ID Number: 107.258

ClinicalTrials.gov Identifier: NCT00042068

Health Authority: United States: Food and Drug Administration