Osteoarthritis, Knee
Conditions
Brief summary
Chondroitin sulfate (CS) is a Symptomatic Slow Acting Drugs for OsteoArthritis (SYSADOA) and a natural biomacromolecule belonging to the class of glycosaminoglycans. CS is a major component of the extracellular matrix (ECM), where it constitutes an essential component of proteoglycans. To this date, no real-world studies have been conducted to precisely describe the burden associated with osteoarthritis (OA) among patients treated with CS.Therefore, an observational, descriptive, prospective, national study will be conducted to describe the burden associated with OA and the quality of life of patients treated with Structum® in Poland.
Detailed description
This is an observational, descriptive, national, multicentric (11 centres), prospective, longitudinal study, which will be conducted over a 6-month follow-up period for each patient. The study will not provide or recommend any specific treatment or procedures. All patients affected by OA in the knee, for whom Structum® is prescribed in a participating center, will be screened in a consecutive manner for eligibility. The study will focus exclusively on patients with OA in the knee as this is the joint most frequently affected and most easily assessed for OA patients. Two additional data collections can be anticipated for these patients as part of their standard of care follow-up visits, which will usually occur around 3 and 6 months after the initial study visit.The patient enrolment period is expected to be 6 months, with a total study duration of 12 months.
Interventions
Chondroitin sulfate (CS) is a natural biomacromolecule belonging to the class of glycosaminoglycans and is an unbranched complex polysaccharide consisting of a repeating disaccharide structure of glucuronic acid and N-acetyl-D-glucosamine \[18\]. It is a major component of the extracellular matrix (ECM), where it constitutes an essential component of proteoglycans. Oral bioavailability of CS has been demonstrated \[19\], and its use for the treatment of OA has been established in animal models \[20\], as well as in clinical trials \[21, 22\]. CS, is available as a pharmaceutical grade drug (Structum®), meaning that the product is manufactured under Good Manufacturing Practices (GMP) conditions, and is in excess of 99% purity with no binders, fillers, excipients, dyes, or unknown substances. According to the Instructions for Use (IFU), the recommended posology for Structum® is 500 mg twice daily.
Sponsors
Pierre Fabre Medicament
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged 50 to 85 years at inclusion * of knee OA (either a patient newly diagnosed \[at inclusion\] or with history of knee OA) based on at least the following items 1 and/or 2: 1. knee pain lasting for at least 3 months; 2. patient in the active phase of knee OA disease (knee pain score ≥ 40mm at inclusion on the Visual Analog Scale \[VAS\] 0-100 mm); 3. knee radiographs showing knee joint narrowing and/or osteophytes. * Patients who have been prescribed, for the first time or not, Structum®. * patient taking any non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics should be on stable dose at least one week before inclusion to the study. * Patients able to visit the clinic and attend follow-up visits. * Patients having signed an informed consent form, according to local regulations.
Exclusion criteria
* Patients with any ongoing chondroitin sulfate treatment at inclusion or during the last 3 months. * plasma (in the last 3 months). No glucocorticoids administration in the last 3 months before inclusion. That does not include NSAIDS, paracetamol and other analgesic medications (e.g. tramadol). * Patients with an artificial knee joint, including unilateral. * Patients scheduled to undergo knee replacement surgery in the next 6 months. * Patients with a severe general condition that prevents them from being included in the study as assessed by the investigator. * Patients participating in interventional trials on investigational drugs at the time of inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osteoarthritis (OA) Symptom Severity (Pain, Stiffness and Function) as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire, for Patients With Knee OA and Treated With Structum®, at Baseline | At baseline (inclusion) | Description of knee OA symptom severity per the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire. The total WOMAC score range is from 0-2400, with higher scores indicating worse pain, stiffness, and functional limitations. |
| Charlson Comorbidity Index Score Measured at Baseline | At baseline (inclusion) | The Charlson Comorbidity Index (CCI) is a scoring system used to predict mortality risk in patients with multiple comorbidities. The index evaluates 17 conditions, with each condition assigned a score based on its severity and the risk of mortality associated with it. The score is rated from 0 to 37. A higher score indicates a higher number of comorbidities. |
| Treatment History Received by the Patients in the Past 6 Months Before Inclusion | From 6 months before inclusion to inclusion (baseline) | Treatment history corresponds to the treatment received or not (yes/no) for knee osteoarthritis in the past 6 months before inclusion in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 3 Months | From baseline (inclusion) to 3 months after baseline | Total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire. Total score at 3 months and mean difference from baseline to 3 months are provided. The total WOMAC score range is from 0-2400, with higher scores indicating worse pain, stiffness and functional limitations. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 6-months | From baseline to 6 months after baseline | Total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire. Total score at 6 months and mean difference from baseline to 6 months are provided. The total WOMAC score range is from 0-2400, with higher scores indicating worse pain, stiffness, and functional limitations. |
| BONe's Questionnaire at Baseline | At baseline (inclusion) | Mean global score of the osteoarthritis burden of the Burden Osteoarthritis New'Scale (BONe'S). The total score range is 0-100 scale. Higher scores represent a heavier burden. |
| BONe's Outcome at 3 Months | From baseline (inclusion) to 3 months after baseline | Mean global score of the OA burden of the Burden Osteoarthritis New'Scale (BONe'S).The total score range is 0-100 scale. Higher scores represent a heavier burden. Global score at 3 months and mean difference from baseline to 3 months are provided. |
| BONe's Outcome at 6 Months | From baseline (inclusion) to 6 months after baseline | Mean global score of the OA burden of the Burden Osteoarthritis New'Scale (BONe'S). The total score range is 0-100 scale. Higher scores represent a heavier burden. The Global score at 6 months and the mean difference from baseline to 6 months are provided. |
| Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at Baseline | At baseline (inclusion) | Global score of general health (physical score component) of the Short Form Questionnaire with 12 questions (SF-12) Scores range from 0 to 100, with higher scores indicating a better physical functioning. |
| Short Form Questionnaire With 12 Questions (SF-12) Outcome: Physical Score Component at 3 Months | From baseline to 3 months after baseline | Global score of general health (physical score component) of the Short Form Questionnaire with 12 questions (SF-12). Scores range from 0 to 100, with higher scores indicating better physical functioning. Global score at 3 months and mean difference from baseline to 3 months are provided. |
| Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at 6 Months | From baseline to 6 months after baseline | Global score of general health (physical score component) of the Short Form Questionnaire with 12 questions (SF-12). Scores range from 0 to 100, with higher scores indicating better physical functioning. Global score at 6 months and mean difference from baseline to 6 months are provided |
| Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at Baseline | Baseline | Global score of mental score component of the Short Form Questionnaire with 12 questions (SF-12). Scores range from 0 to 100, with higher scores indicating a better mental health functioning. |
| Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at 3 Months | From baseline to 3 months after baseline | Global score (mental score component) of the Short Form Questionnaire with 12 questions (SF-12). Scores range from 0 to 100, with higher scores indicating a better mental health functioning. Global score at 3 months and mean difference from baseline to 3 months are provided. |
| Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at 6 Months | From baseline to 6 months | Global score (mental score component) of the Short Form Questionnaire with 12 questions (SF-12). Scores range from 0 to 100, with higher scores indicating a better mental health functionning. Global score at 6 months and mean difference from baseline to 6 months are provided. |
| Persistence Outcomes at 3 Months | At 3 months after baseline | Proportion of patients with ongoing Structum® prescription at 3 months |
| Persistence Outcomes at 6 Months | At 6 months after baseline | Proportion of patients with ongoing Structum® prescription at 6 months |
| Global Score of Patients Satisfaction, After First Dose of Structum®, at 3 Months | At 3 months after baseline | Global statisfaction score of patient at 3 months, as assessed by Structum® treatment satisfaction questionnaire. The Global satisfaction score ranges from 0 to 100. A higher score indicates a higher satisfaction. |
| Global Score of Patient Satisfaction, After First Dose of Structum®, at 6 Months | At 6 months after baseline | Global satisfaction score of patient at 6 months, as assessed by Structum® treatment satisfaction questionnaire. The Global satisfaction score range from 0 to 100. A higher score indicates a higher satisfaction. |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORPIOTR WILAND
Medical University of WROCLAW
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 7.78 |
| Body Mass Index | 28.8 KG/M² STANDARD_DEVIATION 4.2 |
| Region of Enrollment Poland | 136 participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 136 |
| other Total, other adverse events | 9 / 136 |
| serious Total, serious adverse events | 0 / 136 |
Outcome results
None listed