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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05100225
Registration number
NCT05100225
Ethics application status
Date submitted
19/10/2021
Date registered
29/10/2021
Date last updated
19/07/2022
Titles & IDs
Public title
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
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Scientific title
A Multiple Arm, Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
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Secondary ID [1]
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KOA-21-02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - PTP-001
Other interventions - Placebo control
Experimental: PTP-001 200 mg - A single intra-articular injection in the target knee of PTP-001 200 mg.
Experimental: PTP-001 100 mg - A single intra-articular injection in the target knee of PTP-001 100 mg.
Placebo Comparator: Placebo/saline - A single intra-articular injection in the target knee of 4mL of placebo control - physiological saline (0.9% sodium chloride injection, USP).
Other interventions: PTP-001
Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.
Other interventions: Placebo control
The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Efficacy - Change from pretreatment baseline in the WOMAC pain subscale
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Assessment method [1]
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To evaluate the change from pretreatment baseline in the WOMAC pain sub-score in the target knee on an 11-box numerical rating scale, with categories from 0 (none) to 10 (extreme), normalized on scales of 0-100.
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Timepoint [1]
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At 6 months
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Primary outcome [2]
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Safety - Incidence of local and systemic AEs
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Assessment method [2]
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To assess the long-term (6 months) incidence of local and systemic AEs, and consists of physical examination, laboratory values, AEs, AESI, and immunogenicity testing.
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Timepoint [2]
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Over 6 months
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Secondary outcome [1]
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Change from pretreatment baseline in pain intensity assessed by participant self report (WOMAC Pain subscale).
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Assessment method [1]
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WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) is measured on an 11-box numerical rating scale, with categories from 0 (none) to 10 (extreme), normalized to a scale of 0-100, where higher score represents higher pain.
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Timepoint [1]
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At 2 weeks, 3 months, 4 months, 5 months.
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Secondary outcome [2]
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Change from pretreatment baseline in function assessed by participant self-report (WOMAC Function subscale).
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Assessment method [2]
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WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) is measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where higher score represents higher difficulties in physical function.
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Timepoint [2]
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At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
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Secondary outcome [3]
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Change from pretreatment baseline in the weekly average of daily pain assessed by patient self report (NRS).
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Assessment method [3]
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The question is an average daily (24-h) pain intensity score on a 0 to 10 NRS scale with 0 indicating 'no pain' and 10 indicating 'pain as bad as you can imagine'.
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Timepoint [3]
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At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
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Secondary outcome [4]
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Change from pretreatment baseline in patient global assessment of OA (PGA-OA) assessed by participant self report.
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Assessment method [4]
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Considering all the ways knee osteoarthritis affects the participants, the question is an average daily (24-h) self-reported global assessment on an 11-box numerical rating scale, with 0 indicating "very good" and 10 indicating "very poor".
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Timepoint [4]
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At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
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Secondary outcome [5]
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Change from pretreatment baseline in participant self-reported quality of life measured by SF-36 overall score, PCS, and MCS.
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Assessment method [5]
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The SF-36 measures 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health, and has 2 summary scores (physical and mental). The physical health measure includes 4 scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items).
The assessment is performed on a scale of 0 (maximum disability)-100 (no disability) with higher scores indicating better health status.
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Timepoint [5]
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At 3 months and 6 months.
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Secondary outcome [6]
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Response to PTP-001 on the OMERACT-OARSI responder criteria.
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Assessment method [6]
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The OMERACT-OARSI responder criteria involve changes that are deemed to be clinically relevant in the three domains: pain, function, and Patient Global Assessment. For each of these domains, ranges are defined for absolute and percent changes from baseline that correspond to "high improvement" and "moderate improvement". OMERACT-OARSI response is defined as either i) improvement in pain or physical function =50% and an absolute change =20 mm on a 100-mm visual analog scale; or (2) improvement of =20% and with an absolute change =10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment (PGA).
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Timepoint [6]
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At 2 weeks, 3 months, and 6 months.
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Eligibility
Key inclusion criteria
- Participants are eligible to be included in the study only if all of the following
criteria apply:
1. Male or female, aged 40 to 80 years
2. Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3
(mild or moderate) as assessed by the central reading facility
3. Target knee pain = 20 and = 40 out of 50 the WOMAC®NRS 3.1 pain questionnaire
(sum of 5 questions) at screening and baseline
4. Onset of symptomatic OA of the target knee was at least 6 months prior to
screening
5. Insufficient or failed response or intolerance to analgesics and/or non-steroidal
anti-inflammatory drugs, as reported by the participant
6. IF FEMALE, must meet all of the following:
- Not breast feeding
- Not planning to become pregnant during the study
- If of childbearing potential, must have a negative pregnancy test result
within 72 hours prior to receiving the intra-articular injection, and must
commit to the use of a highly effective form of birth control (See Appendix
A) for at least 12 weeks after the injection
7. Willingness to remain on the same oral "rescue" (as needed) analgesic as the only
pharmacologic treatment for knee pain during the study
8. Willingness to abstain from taking any illicit or unauthorized medications for
treatment of OA or any other concurrent condition during the study
9. Written informed consent is obtained from the participant
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Minimum age
40
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants are excluded from the study if any of the following criteria apply:
1. Participant is non-ambulatory (unable to walk >50 feet without assistance)
2. Clinically severe obesity as defined by the National Institutes of Health (body
mass target =40 kg/m2)
3. Contralateral knee pain equal to or exceeding the pain in the target knee (on the
WOMAC® NRS3.1 pain questionnaire) at screening and/or baseline
4. Clinically significant effusion of the target knee at either the screening or
baseline visits determined by physical examination (e.g., ballotable patella or
positive bulge sign). Note: Participants presenting with effusion may be enrolled
in the study after undergoing knee aspiration to remove excess fluid in the
target joint.
5. Severe (excessive) malalignment of the tibial-femoral axis, assessed
radiographically
6. Presence of active infection of the target knee or systemic infection requiring
treatment within the 3 months prior to screening
7. Clinical diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis,
psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.)
established by clinical history, examination, or serology
8. Participant is receiving, has received, or plans to receive any of the following
therapies
- Prior administration of hyaluronic acid, extended release corticosteroid
(e.g., Zilretta®), platelet-rich plasma (PRP), or stem cell therapies by
intra-articular injection(s) of the target knee within 6 months prior to
screening
- Prior intra-articular corticosteroid within 3 months prior to screening or
into any other joint within 30 days prior to screening
- Current chronic systemic use of corticosteroids in doses exceeding 10 mg
prednisolone-equivalents daily
- Treatment with any investigational therapy (drug, device, or biologic)
within 3 months prior to screening or is planned for the duration of the
study
- Treatment with immunosuppressive medication or chemotherapy within the past
5 years
9. Chronic use of narcotics or alcohol abuse within the past 6 months prior to
screening
10. Surgery to the target knee (including arthroscopy) within 6 months prior to
receiving the intra-articular injection or planned surgery to the target knee
within 6 months after the injection
11. Participant previously underwent arthroplasty of the target knee
12. Presence of joint instability or complaints of locking, intermittent limitation
in range of motion, or loose body sensation, suggestive of internal derangement
of the knee (either extremity)
13. Symptomatic OA of the non-target knee that is not responsive to paracetamol
(acetaminophen) or oral nonsteroidal anti-inflammatory drugs (NSAIDs).
14. Diagnosis of lower extremity gout or pseudo-gout in the past 6 months
15. Osteonecrosis of either knee
16. Significant acute (within the past 3 months) injury to the target knee
17. History of receiving a solid organ or hematologic transplant
18. History of malignancy, radiotherapy, or chemotherapy for malignancy within the
past 5 years, except for basal or squamous cell carcinoma of the skin
19. History of prior radiation therapy of the target knee
20. History of autoimmune disease affecting the musculoskeletal system
21. Known (documented) history of acquired immune deficiency syndrome or human
immunodeficiency virus
22. Any condition causing pain in or around the target knee (e.g., radiating pain,
pain in another region of the ipsilateral lower extremity) that may interfere
with assessment(s) of the target knee
23. Other chronic pain anywhere in the body that requires the chronic use of
analgesic medications, such as fibromyalgia, neuropathic pain, low back pain,
etc.
24. Presence of contraindications for use of 3 g/day of orally administered
paracetamol/acetaminophen due to known hypersensitivity or hepatic impairment.
25. Known presence of any concurrent medical condition (e.g., hematologic renal,
hepatic, cardiac, or coagulation abnormalities) that in the investigator's
judgment would interfere with the required study assessments and study
participation
26. Participant is involved in litigation (e.g., worker's compensation) for a medical
condition or injury at any anatomical site
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/11/2022
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Actual
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Sample size
Target
210
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Emeritus Research Sydney - Botany
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Recruitment hospital [2]
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Genesis Research Services - Broadmeadow
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Recruitment hospital [3]
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Royal North Shore Hospital - Saint Leonards
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Recruitment hospital [4]
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Holdsworth House Medical Practice - Sydney
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Recruitment hospital [5]
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Emeritus Research Melbourne - Camberwell
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Recruitment postcode(s) [1]
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2019 - Botany
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Recruitment postcode(s) [2]
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2292 - Broadmeadow
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Recruitment postcode(s) [3]
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- Saint Leonards
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Recruitment postcode(s) [4]
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2010 - Sydney
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Recruitment postcode(s) [5]
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3124 - Camberwell
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Country [2]
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Canada
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State/province [2]
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Quebec
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Denmark
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State/province [3]
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Gandrup
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Country [4]
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Denmark
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State/province [4]
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Herlev
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Country [5]
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Denmark
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State/province [5]
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Vejle
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bioventus LLC
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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NBCD A/S
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Evaluation of safety, tolerability and efficacy of a single intra-articular (IA) injection of
PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis
(OA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05100225
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Trial related presentations / publications
Flannery CR, Seaman SA, Buddin KE, Nasert MA, Semler EJ, Kelley KL, Long M, Favret J, Pavesio A, Loeser RF. A novel placental tissue biologic, PTP-001, inhibits inflammatory and catabolic responses in vitro and prevents pain and cartilage degeneration in a rat model of osteoarthritis. Osteoarthritis Cartilage. 2021 Aug;29(8):1203-1212. doi: 10.1016/j.joca.2021.03.022. Epub 2021 May 20.
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Public notes
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Contacts
Principal investigator
Name
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Moin Khan, MD
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Address
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McMaster University Department of Surgery St. Joseph's Healthcare Hamilton
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05100225
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