Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life

Study Overview
=================
Brief Summary
-----------------
The objective of the observational study is to examine the effect of MOVALIS (Meloxicam) therapy on Health Related Quality of Life (HRQoL) in the diverse region of Central and Eastern Europe. The Medical Outcomes Study 12 Item Short Form Health Survey version 2 (SF-12v2) will be used as the instrument to measure any change in physical wellbeing (Physical Component Summary, PCS) and mental wellbeing (Mental Component Summary, MCS) of patients following MOVALIS (Meloxicam) therapy.

Official Title
-----------------
Assessing the Impact of MOVALIS on Health Related Quality of Life

Conditions
-----------------
Osteoarthritis, Arthritis, Rheumatoid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (according to Summary of Product Characteristics (SPC) ): 1. Male or female patients aged 18 years or above 2 Females of child bearing age must be using adequate contraception (hormonal or barrier method of birth control) 3. Patients with symptoms of acute, painful osteoarthritis or rheumatoid arthritis 4. Patients requiring therapy with non-steroidal anti-inflammatory drugs (NSAIDs) 5. Patients requiring either parenteral and/or oral NSAIDs 6. Patients who have not taken another NSAID or Cyclo-oxygenase-2 (COX-2) inhibitor in the previous 7 days Pain intensity on the visual analogue scale (VAS) 25 mm and above Exclusion Criteria (according to contraindications of Summary of Product Characteristics (SPC) ): Known hypersensitivity to meloxicam or any excipient of the product, known or suspected hypersensitivity to analgesics, antipyretics or NSAIDs Patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of aspirin or other NSAIDs Active peptic ulcer, gastrointestinal perforation or bleeding within the last 6 months Severe liver failure Non-dialysed severe renal failure Pregnancy or breastfeeding Haemostasis disorders or concomitant treatment with anticoagulants Severe congestive heart failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit. | Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing) | baseline and final visit (approximately 4 weeks) | 
| Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2 | Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing) | Baseline and final visit (approximately 4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline of Pain Intensity on Visual Analogue Scale | The effect of MOVALIS® on reduction of pain intensity was assessed by the change from baseline in patient assessment of pain intensity on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain) | Approximately four weeks of treatment | 
| Patient Assessment of Efficacy | Patient assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2. The patients have been placed into categories according to the points on a scale. | after approximately 4 weeks of treatment | 
| Physician Assessment of Efficacy | Physician assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2. The patients have been placed into categories according to the points on a scale. | after approximately 4 weeks of treatment |