Arthritis, Rheumatoid, Osteoarthritis
Conditions
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) ): 1. Known hypersensitivity to meloxicam or any excipient of the product, known or suspected hypersensitivity to analgesics, antipyretics or NSAIDs 2. Patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of aspirin or other NSAIDs 3. Active peptic ulcer, gastrointestinal perforation or bleeding within the last 6 months 4. Severe liver failure 5. Non-dialysed severe renal failure 6. Pregnancy or breastfeeding 7. Haemostasis disorders or concomitant treatment with anticoagulants 8. Severe congestive heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit. | baseline and final visit (approximately 4 weeks) | 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) |
| Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2 | Baseline and final visit (approximately 4 weeks) | Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Pain Intensity on Visual Analogue Scale | Approximately four weeks of treatment | 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) |
| Patient Assessment of Efficacy | after approximately 4 weeks of treatment | 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. |
| Physician Assessment of Efficacy | after approximately 4 weeks of treatment | 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. |
Countries
Croatia, Czechia, Estonia, Russia, Slovakia
Participant flow
Pre-assignment details
Number of patients: * treated set = 3569 (treated with Movalis) * full analysis set = 3473 (patients completed 2 visits and had baseline and final 12-item Short-Form Health Survey (SF12) score)
Participants by arm
| Arm | Count |
|---|---|
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician | 3,569 |
| Total | 3,569 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 18 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Missing termination information | 481 |
| Overall Study | Not specified reasons | 6 |
Baseline characteristics
| Characteristic | Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 13.8 |
| Sex/Gender, Customized Female | 2355 participants |
| Sex/Gender, Customized Male | 1167 participants |
| Sex/Gender, Customized Missing | 47 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3,569 |
| serious Total, serious adverse events | 0 / 3,569 |
Outcome results
Primary
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)
Time frame: baseline and final visit (approximately 4 weeks)
Population: A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit. | 11.2 Units on a scale | Standard Deviation 9.5 |
Primary
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)
Time frame: Baseline and final visit (approximately 4 weeks)
Population: A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2 | 6.2 Units on a scale | Standard Deviation 10.1 |
Secondary
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)
Time frame: Approximately four weeks of treatment
Population: Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on pain intensity on VAS at baseline and final visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Change From Baseline of Pain Intensity on Visual Analogue Scale | 41.9 Units on a scale | Standard Deviation 18.9 |
Secondary
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.
Time frame: after approximately 4 weeks of treatment
Population: Full analysis set (FAS). This analysis was performed on all patients in FAS with available data on the global assessment of general efficacy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Patient Assessment of Efficacy | Excellent | 803 Participants |
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Patient Assessment of Efficacy | Very Good | 1540 Participants |
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Patient Assessment of Efficacy | Good | 928 Participants |
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Patient Assessment of Efficacy | Fair | 161 Participants |
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Patient Assessment of Efficacy | Poor | 29 Participants |
Secondary
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.
Time frame: after approximately 4 weeks of treatment
Population: Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on physician assessment of efficacy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Physician Assessment of Efficacy | Good | 806 Participants |
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Physician Assessment of Efficacy | Excellent | 879 Participants |
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Physician Assessment of Efficacy | Very Good | 1652 Participants |
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Physician Assessment of Efficacy | Fair | 109 Participants |
| Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection | Physician Assessment of Efficacy | Poor | 21 Participants |