The purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain. The study duration will be up to 34 weeks. Participants who completed pDay 162 of Study PARA\_OA\_002 (i.e. did not discontinue/withdraw prematurely from the parent study) will be invited to participate.
This is an observational study to determine duration of treatment effect and assess long-term safety up to 52 weeks post PPS use for 6 weeks in parent study (PARA\_OA\_002). The duration of treatment effect will be evaluated by the OMERACT-OARSI responder criteria for knee OA. Eligible participants will be enrolled in Study PARA\_OA\_006 at the completion of the parent study PARA\_OA\_002. There will be no intervention in this observational study. Participants will attend screening (visit 1), three phone visits at 8, 16, and 24 weeks, and an EOS (end of study) visit 34 weeks at the site, a total of 5 visits. Participants questionnaires include WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) NRS 3.1 Index, PGIC (Patients Global Impression of Change), WPAI (Work Productivity and Activity Impairment) and quality of life SF-36.
Study Type
OBSERVATIONAL
Enrollment
133
Subcutaneous Injection (100mg/ml)
Placebo to match PPS
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Emeritus Research
Camberwell, Victoria, Australia
Assess duration of treatment effect of PPS in participants with OA pain
Time from initial response in the parent study (PARA\_OA\_002) to loss of OMERACT-OARSI (Outcomes Measures in Rheumatology - Osteoarthritis Research Society International) response.
Time frame: From initial response time baseline in parent study up to 34 weeks
Assess duration of treatment effect of PPS in participants with OA pain
Percentage of participants considered OMERACT- OARSI (Outcomes Measures in Rheumatology - Osteoarthritis Research Society International) responders at each timepoint..
Time frame: Week 8, 16, 24, and 34
Assess efficacy of PPS treatment on knee pain in participants with knee OA pain
WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) Index Pain average subscale score. Reduction in knee pain of ≥30% and ≥50% as assessed by the average pain WOMAC NRS 3.1 subscale score. Ranges 0-10 with 0 represents no pain and 10 represents extreme pain.
Time frame: Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) assessment of knee function in participants with knee OA pain
WOMAC NRS 3.1 Index Function WOMAC NRS 3.1 Index.. Improvement of function assessed of ≥30% and ≥50% as assessed by the average Function subscale score (knee) during the past 48 hours. Ranges Scoring 0-10, 0 is better or none and 10 is worse.
Time frame: Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) knee stiffness assessment in participants with knee OA
WOMAC NRS 3.1 Index Stiffness average subscale score. Ranges 0-10, 0 is better or none and 10 is extreme or worse.
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Time frame: Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Overall score WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) in participants with knee OA
WOMAC NRS 3.1 Index Overall average subscale score The WOMAC® NRS 3.1 Index consists of 24 questions and produces 3 sub-scales scores for pain (5 questions), stiffness (2 questions), and function (17 questions) and a total score that summarizes overall disability. Score of 0 is better and the higher score is worse
Time frame: Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Assess effect of PPS on Patient Global Impression of Change (PGIC) in participants with knee OA pain
The PGIC is a self-administered question that rates participants overall improvement in chronic pain since beginning treatment from 1 "no change (or condition has worsened)" to 7 "a great deal better" in response to the question "Since beginning treatment, how would you describe the change (if any) in activity, limitation, symptoms, emotions, and overall QoL related to your arthritis".
Time frame: Weeks 8, 16, 24 and 34
Change from baseline of the parent study in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)
The SF-36 v2 is a 36-item, patient-reported survey of patient health, consisting of 8 scaled scores, which are the weighted sums of the questions in their section. The 1-week recall form asks the respondent to answer the questions as they pertain to the way he or she felt or acted during the past week. Score ranges 0-100 higher scores indicate better health.
Time frame: Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
Change from baseline of the parent study in Work Productivity and Activity Impairment (WPAI) questionnaire.
This WPAI questionnaire (WPAI:OA-knee) is a validated self-administered questionnaire that assesses work impairment due to OA . The questionnaire gathers information on employment status, hours worked, hours missed due to OA, and hours missed for any other reasons
Time frame: Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
Assess real-world use of pain medications/therapies, following a single course of PPS
Number of days rescue medication used or use of other pain medications and therapies
Time frame: Baseline up to Week 34
Incidence of treatment-emergent AE's, SAE's and AESI of PPS is participants with knee OA pain
Data of SAE's, AE's, causally to IP, AE's of Special Interest (AEST), AE's requiring any intervention for index knee pain and AE's requiring pain medication.
Time frame: Baseline up to Week 34