Clinical trial NCT04814719: An Observational Follow-up Study to Evaluate Duration of Treatment Effect of Pentosan Polysulfate Sodium in Participants With Knee Osteoarthritis Pain
Official title: An Observational Follow-up Study to Investigate the Duration of Treatment Effect With Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Knee
Lead sponsor: Paradigm Biopharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who completed pDay 168 of Study PARA_OA_002 (ie, did not discontinue/withdraw prematurely from the parent study).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the duration of treatment effect of PPS in participants with OA pain
timeFrame: From initial response time baseline in parent study up to 34 weeks
Secondary outcomes:
measure: To evaluate the duration of treatment effect of PPS in participants with OA pain
timeFrame: Week 8, 16, 24, and 34
measure: To evaluate the efficacy of PPS treatment on knee pain in participants with knee OA pain
timeFrame: Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
measure: WOMAC NRS 3.1 assessment of knee function in participants with knee OA pain
timeFrame: Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
measure: WOMAC NRS 3.1 knee stiffness assessment in participants with knee OA
timeFrame: Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
measure: Overall score WOMAC NRS 3.1in participants with knee OA
timeFrame: Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
measure: To evaluate the effect of PPS on Patient Global Impression of Change (PGIC) in participants with knee OA pain
timeFrame: Weeks 8, 16, 24 and 34
measure: Change from baseline of the parent study in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)
timeFrame: Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
measure: Change from baseline of the parent study in Work Productivity and Activity Impairment (WPAI) questionnaire.
timeFrame: Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
measure: To evaluate the real-world use of pain medications/therapies, following a single course of PPS
timeFrame: Baseline up to Week 34
measure: To Evaluate the safety and tolerability of PPS is participants with knee OA pain
timeFrame: Baseline up to Week 34
Other outcomes:
measure: Change in subchondral Bone Marrow Lesion (BML) area and volume on Magnetic Resonance Imaging (MRI) from baseline of the parent study .
timeFrame: Baseline (parent study) pDay1 and at Week 34
measure: Change in joint synovitis/effusion volume on MRI
timeFrame: Baseline (parent study) pDay1 and at Week 34
measure: Effect of PPS on Change in cartilage volume on MRI
timeFrame: Baseline (parent study) pDay1 and at Week 34
measure: Change in bone shape on MRI and whether these correlate with clinical outcomes
timeFrame: Baseline (parent study) pDay1 and at Week 34
measure: Change in joint space width on X-ray
timeFrame: Baseline (parent study) pDay1 and at Week 34
measure: Change in joint space width on MRI
timeFrame: Baseline (parent study) pDay1 and at Week 34
measure: Explore any correlation between joint space width measurements from x-rays and MRI
timeFrame: Week 34
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Thomas Schnitzer
role: PRINCIPAL_INVESTIGATOR
References: