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

Study Overview
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Brief Summary
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This was a study to estimate the proportion of participants with osteoarthritis of the knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did not report adequate pain relief at Baseline and to characterize their pain level over a 12-month follow-up period.

Official Title
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Survey of Osteoarthritis Real World Therapies (SORT)

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Standard of care for treatment of osteoarthritis (OA) of knee(s)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of primary osteoarthritis of the knee(s) Presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment Exclusion Criteria: Arthritis other than primary osteoarthritis Treatment with disease-modifying antirheumatic drugs (DMARDS), methotrexate or biologics Subtotal or total joint replacement in the affected knee Chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study Currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Enrolled Participants<br>All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician. | Drug: Standard of care for treatment of osteoarthritis (OA) of knee(s)<br>* All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief 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). | Baseline (Day 1) | 
| Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief 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). | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1) | 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. | Baseline (Day 1) | 
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function 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. | Month 1 | 
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function 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. | Month 3 | 
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function 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. | Month 6 | 
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function 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. | Month 9 | 
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function 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. | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Standard of care