Trial Outcomes & Findings for Survey of Osteoarthritis Real World Therapies (MK-0663-140) (NCT NCT01294696)
NCT ID: NCT01294696
Last Updated: 2024-08-29
Results Overview
Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of \<=4 on question 5 of the BPI. Inadequate pain control was defined as a score \>4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).
COMPLETED
1261 participants
Baseline (Day 1)
2024-08-29
Participant Flow
The study was conducted in 54 trial centers: 18 in France; 4 in Italy; 5 in The Netherlands; 5 in Portugal; and 9 in the United Kingdom.
Participant milestones
| Measure |
All Enrolled Participants
The population consisted of all enrolled participants with adequate and inadequate pain relief.
|
|---|---|
|
Overall Study
STARTED
|
1261
|
|
Overall Study
COMPLETED
|
1187
|
|
Overall Study
NOT COMPLETED
|
74
|
Reasons for withdrawal
| Measure |
All Enrolled Participants
The population consisted of all enrolled participants with adequate and inadequate pain relief.
|
|---|---|
|
Overall Study
Screening failures
|
7
|
|
Overall Study
Protocol Violation
|
8
|
|
Overall Study
Missing BPI Response
|
7
|
|
Overall Study
Site closure
|
52
|
Baseline Characteristics
Survey of Osteoarthritis Real World Therapies (MK-0663-140)
Baseline characteristics by cohort
| Measure |
Participants With Adequate Pain Relief
n=548 Participants
Adequate pain relief was defined as an average pain score of \<=4 on the Brief Pain Inventory (BPI). Baseline characteristics are only reported for participants with data available at baseline.
|
Participants With Inadequate Pain Relief
n=639 Participants
Inadequate pain relief was defined as an average pain score of \>4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
|
Total
n=1187 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 Years
STANDARD_DEVIATION 9.03 • n=99 Participants
|
68.0 Years
STANDARD_DEVIATION 9.76 • n=107 Participants
|
67.8 Years
STANDARD_DEVIATION 9.43 • n=206 Participants
|
|
Sex: Female, Male
Female
|
329 Participants
n=99 Participants
|
479 Participants
n=107 Participants
|
808 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
219 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
379 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1)Population: The population consisted of all participants for which a BPI value was available at baseline.
Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of \<=4 on question 5 of the BPI. Inadequate pain control was defined as a score \>4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).
Outcome measures
| Measure |
All Enrolled Participants
n=1187 Participants
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
|
|---|---|
|
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline
Adequate Pain Relief
|
46.2 Percentage of Participants
|
|
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline
Inadequate Pain Relief
|
53.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Month 12Population: The population consisted of all participants for which a BPI value was avaialble at Month 12.
Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of \<=4 on question 5 of the BPI. Inadequate pain control was defined as a score \>4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).
Outcome measures
| Measure |
All Enrolled Participants
n=1074 Participants
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
|
|---|---|
|
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12
Adequate Pain Relief
|
47.3 Percentage of Participants
|
|
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12
Inadequate Pain Relief
|
52.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: The population consisted of all participants for which WOMAC VA 3.0 data for joint stiffness and limiation in physical function were available at Baseline.
Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Outcome measures
| Measure |
All Enrolled Participants
n=1097 Participants
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
|
|---|---|
|
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)
|
43.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 1Population: The population consisted of all participants for which a WOMAC VA 3.0 measurement was available at Month 1.
Joint stiffness or limitation in physical function was evaluated using the Western Ontario McMaster Osteoarthritis (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Outcome measures
| Measure |
All Enrolled Participants
n=1026 Participants
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
|
|---|---|
|
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1
|
44.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 3Population: The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 3.
Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Outcome measures
| Measure |
All Enrolled Participants
n=1013 Participants
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
|
|---|---|
|
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3
|
44.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 6Population: The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 6.
Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Outcome measures
| Measure |
All Enrolled Participants
n=1070 Participants
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
|
|---|---|
|
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6
|
45.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 9Population: The population consistated of all participants for which WOMAC VA 3.0 data were available at Month 9.
Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Outcome measures
| Measure |
All Enrolled Participants
n=1039 Participants
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
|
|---|---|
|
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9
|
48.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 12Population: The population consisted of all participants for which WOMAC VA 3.0 data was available at Month 12.
Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Outcome measures
| Measure |
All Enrolled Participants
n=1058 Participants
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
|
|---|---|
|
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12
|
49.6 Percentage of Participants
|
Adverse Events
Participants With Adequate Pain Relief
Participants With Inadequate Pain Relief
Serious adverse events
| Measure |
Participants With Adequate Pain Relief
n=548 participants at risk
Adequate pain relief was fedined as an average pain score of \<=4 on the Brief Pain Inventory (BPI).
|
Participants With Inadequate Pain Relief
n=639 participants at risk
Inadequate pain relief was defined as an average pain score of \>4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Cardiac disorders
Palpitations
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Eye disorders
Cataract
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 2 • Up to Month 12
|
|
Gastrointestinal disorders
Abdominal Distention
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Gastrointestinal disorders
Nausea
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
General disorders
Death
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
General disorders
Oedema Peripheral
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Infections and infestations
Abscess
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Infections and infestations
Cellulitis
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Infections and infestations
Influenza
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Infections and infestations
Localized Infection
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Infections and infestations
Periumbilical Abscess
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Infections and infestations
Pneumonia
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Infections and infestations
Sepsis
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Injury, poisoning and procedural complications
Burns Third Degree
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Injury, poisoning and procedural complications
Fracture
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/548 • Up to Month 12
|
0.63%
4/639 • Number of events 4 • Up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Nervous system disorders
Parkinson's Disease
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Renal and urinary disorders
Calculus Bladder
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Renal and urinary disorders
Urethral Sclerosis
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/548 • Up to Month 12
|
0.16%
1/639 • Number of events 1 • Up to Month 12
|
|
Vascular disorders
Hypotension
|
0.18%
1/548 • Number of events 1 • Up to Month 12
|
0.00%
0/639 • Up to Month 12
|
Other adverse events
Adverse event data not reported
Additional Information
Vice President, Late Stage Group Development Leader
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER