Trial Outcomes & Findings for Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life (NCT NCT00619177)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

3569 participants

Primary outcome timeframe

baseline and final visit (approximately 4 weeks)

Results posted on

2015-02-16

Participant Flow

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)

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	3569
Overall Study COMPLETED	3061
Overall Study NOT COMPLETED	508

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	18
Overall Study Lost to Follow-up	2
Overall Study Lack of Efficacy	1
Overall Study Missing termination information	481
Overall Study Not specified reasons	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection n=3569 Participants 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
Age, Continuous	57 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex/Gender, Customized Female	2355 participants n=5 Participants
Sex/Gender, Customized Male	1167 participants n=5 Participants
Sex/Gender, Customized Missing	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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)

Outcome measures

Outcome measures
Measure	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection n=3473 Participants 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
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 outcome

Timeframe: 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).

Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)

Outcome measures

Outcome measures
Measure	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection n=3473 Participants 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
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 outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection n=3459 Participants 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
Change From Baseline of Pain Intensity on Visual Analogue Scale	41.9 Units on a scale Standard Deviation 18.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection n=3461 Participants 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
Patient Assessment of Efficacy Excellent	803 Participants
Patient Assessment of Efficacy Very Good	1540 Participants
Patient Assessment of Efficacy Good	928 Participants
Patient Assessment of Efficacy Fair	161 Participants
Patient Assessment of Efficacy Poor	29 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection n=3467 Participants 7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
Physician Assessment of Efficacy Excellent	879 Participants
Physician Assessment of Efficacy Very Good	1652 Participants
Physician Assessment of Efficacy Good	806 Participants
Physician Assessment of Efficacy Fair	109 Participants
Physician Assessment of Efficacy Poor	21 Participants

Adverse Events

Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER