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Survey of Osteoarthritis Real World Therapies (MK-0663-140) (SORT)

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ClinicalTrials.gov Identifier: NCT01294696
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : March 4, 2014
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Osteoarthritis
Intervention Drug: Standard of care for treatment of osteoarthritis (OA) of knee(s)
Enrollment 1261
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description The population consisted of all enrolled participants with adequate and inadequate pain relief.
Period Title: Overall Study
Started 1261
Completed 1187
Not Completed 74
Reason Not Completed
Screening failures             7
Protocol Violation             8
Missing BPI Response             7
Site closure             52
Arm/Group Title Participants With Adequate Pain Relief Participants With Inadequate Pain Relief Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 548 639 1187
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 548 participants 639 participants 1187 participants
67.6  (9.03) 68.0  (9.76) 67.8  (9.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 548 participants 639 participants 1187 participants
Female
329
  60.0%
479
  75.0%
808
  68.1%
Male
219
  40.0%
160
  25.0%
379
  31.9%
1.Primary Outcome
Title Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline
Hide Description 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).
Time Frame Baseline (Day 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants for which a BPI value was available at baseline.
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
Overall Number of Participants Analyzed 1187
Measure Type: Number
Unit of Measure: Percentage of Participants
Adequate Pain Relief 46.2
Inadequate Pain Relief 53.8
2.Primary Outcome
Title Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12
Hide Description 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).
Time Frame Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants for which a BPI value was avaialble at Month 12.
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
Overall Number of Participants Analyzed 1074
Measure Type: Number
Unit of Measure: Percentage of Participants
Adequate Pain Relief 47.3
Inadequate Pain Relief 52.7
3.Secondary Outcome
Title Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)
Hide Description 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.
Time Frame Baseline (Day 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
Overall Number of Participants Analyzed 1097
Measure Type: Number
Unit of Measure: Percentage of Participants
43.4
4.Secondary Outcome
Title Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1
Hide Description 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.
Time Frame Month 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants for which a WOMAC VA 3.0 measurement was available at Month 1.
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
Overall Number of Participants Analyzed 1026
Measure Type: Number
Unit of Measure: Percentage of Participants
44.8
5.Secondary Outcome
Title Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3
Hide Description 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.
Time Frame Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 3.
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
Overall Number of Participants Analyzed 1013
Measure Type: Number
Unit of Measure: Percentage of Participants
44.7
6.Secondary Outcome
Title Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6
Hide Description 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.
Time Frame Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 6.
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
Overall Number of Participants Analyzed 1070
Measure Type: Number
Unit of Measure: Percentage of Participants
45.3
7.Secondary Outcome
Title Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9
Hide Description 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.
Time Frame Month 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consistated of all participants for which WOMAC VA 3.0 data were available at Month 9.
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
Overall Number of Participants Analyzed 1039
Measure Type: Number
Unit of Measure: Percentage of Participants
48.6
8.Secondary Outcome
Title Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12
Hide Description 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.
Time Frame Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants for which WOMAC VA 3.0 data was available at Month 12.
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
Overall Number of Participants Analyzed 1058
Measure Type: Number
Unit of Measure: Percentage of Participants
49.6
Time Frame Up to Month 12
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants With Adequate Pain Relief Participants With Inadequate Pain Relief
Hide Arm/Group Description Adequate pain relief was fedined as an average pain score of <=4 on the Brief Pain Inventory (BPI). 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.
All-Cause Mortality
Participants With Adequate Pain Relief Participants With Inadequate Pain Relief
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Adequate Pain Relief Participants With Inadequate Pain Relief
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/548 (2.01%)      25/639 (3.91%)    
Blood and lymphatic system disorders     
Anaemia  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Cardiac disorders     
Angina Unstable  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Palpitations  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Eye disorders     
Cataract  1  0/548 (0.00%)  0 1/639 (0.16%)  2
Gastrointestinal disorders     
Abdominal Distention  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Diarrhoea  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Nausea  1  1/548 (0.18%)  1 0/639 (0.00%)  0
General disorders     
Death  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Oedema Peripheral  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Infections and infestations     
Abscess  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Cellulitis  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Influenza  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Localized Infection  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Neutropenic Sepsis  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Periumbilical Abscess  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Pneumonia  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Sepsis  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Injury, poisoning and procedural complications     
Burns Third Degree  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Fall  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Femoral Neck Fracture  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Fracture  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Radius Fracture  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Wrist Fracture  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Arthritis  1  1/548 (0.18%)  1 1/639 (0.16%)  1
Bone Pain  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Foot Deformity  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Osteoarthritis  1  0/548 (0.00%)  0 4/639 (0.63%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Neoplasm  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Bladder Transitional Cell Carcinoma  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Chronic Lymphocytic Leukaemia  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Lung Neoplasm Malignant  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Malignant Melanoma  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Neoplasm  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Nervous system disorders     
Cerebrovascular Accident  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Haemorrhagic Stroke  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Parkinson's Disease  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Transient Ischaemic Attack  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Renal and urinary disorders     
Calculus Bladder  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Renal Colic  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Urethral Sclerosis  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic Respiratory Failure  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Pneumonia Aspiration  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Respiratory Failure  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Skin and subcutaneous tissue disorders     
Skin Ulcer  1  0/548 (0.00%)  0 1/639 (0.16%)  1
Vascular disorders     
Hypotension  1  1/548 (0.18%)  1 0/639 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Participants With Adequate Pain Relief Participants With Inadequate Pain Relief
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/548 (0.00%)      0/639 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Vice President, Late Stage Group Development Leader
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01294696     History of Changes
Other Study ID Numbers: 0663-140
First Submitted: December 22, 2010
First Posted: February 11, 2011
Results First Submitted: January 21, 2014
Results First Posted: March 4, 2014
Last Update Posted: April 4, 2017