A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: Meloxicam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Meloxicam|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response according to American College of Rheumatology 20% (ACR20) classification |  | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| C-Reactive Protein (CRP) |  | up to 12 weeks | 
| Withdrawal due to lack of efficacy |  | 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 | 
| 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 | 
| Use of rescue medication |  | up to 12 weeks | 
| Incidence and intensity of adverse events |  | until 4 weeks post treatment | 
| Patient's final global assessment of tolerability |  | at end of 12 weeks | 
| Investigator's final global assessment of tolerability |  | at end of 12 weeks | 
| Withdrawals due to adverse events |  | at end of 12 weeks |