An Observational Follow-up Study to Evaluate Duration of Treatment Effect of Pentosan Polysulfate Sodium in Participants With Knee Osteoarthritis Pain

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04814719
• Other study ID #: PARA_OA_006
• Status: Active, not recruiting
• Start date: June 24, 2023
• Est. completion date: December 24, 2025

Study information

• Verified date: April 2024
• Source: Paradigm Biopharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: December 24, 2025
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Pentosan Polysulphate Sodium
Subcutaneous Injection (100mg/ml)
• Placebo (Sodium Chloride Injection, 0.9%)
Placebo to match PPS

Locations

Country	Name	City	State
Australia	Emeritus Research	Camberwell	Victoria
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Paradigm Biopharmaceuticals USA (INC)

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in subchondral Bone Marrow Lesion (BML) area and volume on Magnetic Resonance Imaging (MRI) from baseline of the parent study .	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	Baseline (parent study) pDay1 and at Week 34
Other	Change in joint synovitis/effusion volume on MRI	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	Baseline (parent study) pDay1 and at Week 34
Other	Effect of PPS on Change in cartilage volume on MRI	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	Baseline (parent study) pDay1 and at Week 34
Other	Change in bone shape on MRI and whether these correlate with clinical outcomes	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	Baseline (parent study) pDay1 and at Week 34
Other	Change in joint space width on X-ray	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	Baseline (parent study) pDay1 and at Week 34
Other	Change in joint space width on MRI	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	Baseline (parent study) pDay1 and at Week 34
Other	Explore any correlation between joint space width measurements from x-rays and MRI	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.	Week 34
Primary	To evaluate the 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 response.	From initial response time baseline in parent study up to 34 weeks
Secondary	To evaluate the duration of treatment effect of PPS in participants with OA pain	Percentage of participants considered OMERACT- OARSI responders at each timepoint..	Week 8, 16, 24, and 34
Secondary	To evaluate the efficacy of PPS treatment on knee pain in participants with knee OA pain	WOMAC NRS 3.1 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	Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Secondary	WOMAC NRS 3.1 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.	Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Secondary	WOMAC NRS 3.1 knee stiffness assessment in participants with knee OA	WOMAC NRS 3.1 Index Stiffness average subscale score.	Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Secondary	Overall score WOMAC NRS 3.1in 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	Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Secondary	To evaluate the 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".	Weeks 8, 16, 24 and 34
Secondary	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.	Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
Secondary	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	Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
Secondary	To evaluate the 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	Baseline up to Week 34
Secondary	To Evaluate the safety and tolerability of PPS is participants with knee OA pain	Incidence of SAE's, AE's, causally to IP, AE's of Special Interest (AEST), AE's requireing any intervention for index knee pain and AE's requiring pain medication.	Baseline up to Week 34