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

Boehringer Ingelheim83 sites in 7 countries1,000 target enrollmentJune 2002

ConditionsArthritis, Rheumatoid

DrugsMeloxicam

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Arthritis, Rheumatoid
Sponsor: Boehringer Ingelheim
Enrollment: 1000
Locations: 83
Primary Endpoint: Response according to American College of Rheumatology 20% (ACR20) classification
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2002

End Date

July 2003

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Response according to American College of Rheumatology 20% (ACR20) classification

Time Frame: at 12 weeks

Secondary Outcomes

Investigator's final global (overall) assessment of efficacy(at end of 12 weeks)
Patient status with regard to change in arthritic condition(at end of 12 weeks)
Number of painful or tender joints(up to 12 weeks)
Number of swollen joints(up to 12 weeks)
Patient's global (overall) assessment of disease activity(up to 12 weeks)
Investigator's global (overall) assessment of disease activity(up to 12 weeks)
Patient's assessment of pain(up to 12 weeks)
Patient's assessment of physical function (mHAQ)(up to 12 weeks)
Withdrawal due to lack of efficacy(up to 12 weeks)
Use of rescue medication(up to 12 weeks)
Patient's final global assessment of tolerability(at end of 12 weeks)
Investigator's final global assessment of tolerability(at end of 12 weeks)
C-Reactive Protein (CRP)(up to 12 weeks)
Duration of morning stiffness(up to of 12 weeks)
Patient's final global (overall) assessment of efficacy(at end of 12 weeks)
Incidence and intensity of adverse events(until 4 weeks post treatment)
Withdrawals due to adverse events(at end of 12 weeks)