Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Knee
Brief summary
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.
Detailed description
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.
Interventions
Placebo to match PPS
DRUGPentosan Polysulphate Sodium
Subcutaneous Injection (100mg/ml)
Sponsors
Paradigm Biopharmaceuticals Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who completed Day 168 of Study PARA\_OA\_002 (ie, did not discontinue/withdrew prematurely from the parent study). * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
• An employee of the Sponsor, clinical research organisations or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess duration of treatment effect of PPS in participants with OA pain | From initial response time baseline in parent study up to 34 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) assessment of knee function in participants with knee OA pain | Baseline (parent study) pDay1, weeks 8, 16, 24, and 34 | 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. |
| WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) knee stiffness assessment in participants with knee OA | Baseline (parent study) pDay1, weeks 8, 16, 24, and 34 | WOMAC NRS 3.1 Index Stiffness average subscale score. Ranges 0-10, 0 is better or none and 10 is extreme or worse. |
| Overall score WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) in participants with knee OA | Baseline (parent study) pDay1, weeks 8, 16, 24, and 34 | 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 |
| Assess effect of PPS on Patient Global Impression of Change (PGIC) in participants with knee OA pain | Weeks 8, 16, 24 and 34 | 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. |
| Change from baseline of the parent study in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36) | Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34 | 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. |
| Change from baseline of the parent study in Work Productivity and Activity Impairment (WPAI) questionnaire. | Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34 | 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 |
| Assess real-world use of pain medications/therapies, following a single course of PPS | Baseline up to Week 34 | Number of days rescue medication used or use of other pain medications and therapies |
| Incidence of treatment-emergent AE's, SAE's and AESI of PPS is participants with knee OA pain | Baseline up to Week 34 | 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. |
| Assess duration of treatment effect of PPS in participants with OA pain | Week 8, 16, 24, and 34 | Percentage of participants considered OMERACT- OARSI (Outcomes Measures in Rheumatology - Osteoarthritis Research Society International) responders at each timepoint.. |
| Assess efficacy of PPS treatment on knee pain in participants with knee OA pain | Baseline (parent study) pDay1, weeks 8, 16, 24, and 34 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in subchondral Bone Marrow Lesion (BML) on Magnetic Resonance Imaging (MRI) from baseline of the parent study. | Baseline (parent study) pDay1 and at Week 34 | MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate |
| Change in joint synovitis/effusion volume on MRI | Baseline (parent study) pDay1 and at Week 34 | MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate |
| Change in joint space width on X-ray | Baseline (parent study) pDay1 and at Week 34 | X-Rays will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate |
| Change in joint space width on MRI | Baseline (parent study) pDay1 and at Week 34 | MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate |
| Explore any correlation between joint space width measurements from x-rays and MRI | Week 34 | MRIs and x-rays will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans and x-rays. All measurement will be done in duplicate. |
| Effect of PPS on Change in cartilage volume on MRI | Baseline (parent study) pDay1 and at Week 34 | MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate |
| Change in bone shape on MRI and whether these correlate with clinical outcomes | Baseline (parent study) pDay1 and at Week 34 | MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate |
Countries
Australia, United States
Outcome results
None listed