Study on Structum® in Adult Patients With Osteoarthritis (TRUST)

Pierre Fabre Medicament151 enrolled

Overview

Chondroitin sulfate (CS) is a 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 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.

This is an observational, descriptive, national, multicentric, 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.

Study Type

OBSERVATIONAL

Enrollment

151

Conditions

Osteoarthritis, Knee

Interventions

Chondroitin sulfateDRUG

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female patients aged 50 to 80 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®. * If patient is taking any NSAIDs or other analgesics, patient could 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.

Locations (15)

Maciej Dołżyński

Bialystok, Poland

Piotr Ligocki

Bydgoszcz, Poland

Elżbieta Pietrus- Dunaszewska

Katowice, Poland

Outcomes

Primary Outcomes

describe the baseline clinical profile and baseline OA symptom severity (pain, stiffness and function) as assessed by the (WOMAC) questionnaire, for patients with knee OA and treated with Structum®.

description at enrollment of Demographics and clinical characteristics of patients with knee OA- description of treatment history- description of knee OA symptm 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.

Time frame: baseline

Secondary Outcomes

Secondary Womac outcomes at 3-months

Mean global score of symptoms severity of 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.

Time frame: from baseline to 3 months after baseline

Secondary Womac outcomes at 3-months

Mean score of each dimension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC )Questionnaire. For each dimension, the values scored on each item will be summed to give a dimension score, with pain ranging from 0-500, stiffness 0-200, and physical function 0-1700.

Time frame: from baseline to 3 months after baseline

Secondary Womac outcomes at 3-months

Mean difference in symptoms severity score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC )Questionnaire.

Time frame: from baseline to 3 months after baseline

Secondary Womac outcomes at 6-months

Mean difference in symptoms severity score of 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.

Data from ClinicalTrials.gov

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Bartlomiej Szpyra

Krakow, Poland

Alina Wołkowicz Mruk

Krakow, Poland

Andrzej Majer

Kujakowice Gorn, Poland

Agnieska WIAK

Lubartów, Poland

Wojciech Larczyński

Nowy Dwór Gdański, Poland

Sławomir Panek

Olesno, Poland

Marcin Milchert

Szczecin, Poland

...and 5 more locations

Time frame: from baseline to 6 months after baseline

Secondary Womac outcomes at 6-months

Time frame: from baseline to 6 months after baseline

Secondary Womac outcomes at 6-months

Mean global score of symptom severity of 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.

Time frame: from baseline to 6 months after baseline

Bone's outcome at 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

Time frame: baseline

Bone's outcome at baseline

Mean score of each dimension of the Burden Osteoarthritis New'Scale (BONe'S) Each question (19 questions) of each dimension is evaluated from to 5.

Time frame: baseline

Bone's outcome at 3 months

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

Time frame: from baseline to 3 months after baseline

Bone's outcome at 6 months

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

Time frame: from baseline to 6months after baseline

Bone's outcome at 3 months

Mean score of each dimension of the Burden Osteoarthritis New'Scale (BONe'S) Each question (19 questions) of each dimension is evaluated from to 5.

Time frame: from baseline to 3 months after baseline

Bone's outcome at 6 months

Mean score of each dimension of the Burden Osteoarthritis New'Scale (BONe'S) The total score range is 0-100 scale. Higher scores represent a heavier burden

Time frame: from baseline to 6 months after baseline

Bone's outcome at 3 months

Mean difference in OA burden scores at 3 months of the Burden Osteoarthritis New'Scale (BONe'S) The total score range is 0-100 scale. Higher scores represent a heavier burden

Time frame: from baseline to 3 months after baseline

Bone's outcome at 6 months

Mean difference in OA burden scores at 6 months of the Burden Osteoarthritis New'Scale (BONe'S) The total score range is 0-100 scale. Higher scores represent a heavier burden

Time frame: from baseline to 6 months after baseline

SF12 outcome at baseline

mean global score of general health of the Short Form Questionnaire (SF12) Scores range from 0 to 100, with higher scores indicating a better physical and mental health functioning.

Time frame: baseline

SF12 outcome at 3 months

mean global score of general health of the Short Form Questionnaire (SF12) Scores range from 0 to 100, with higher scores indicating a better physical and mental health functioning.

Time frame: from baseline to 3 months after baseline

SF12 outcome at 6 months

mean global score of general health of the Short Form Questionnaire (SF12) Scores range from 0 to 100, with higher scores indicating a better physical and mental health functioning.

Time frame: from baseline to 6 months after baseline

SF12 outcome at baseline

mean score of physical and mental dimension of the Short Form Questionnaire (SF12) A special scoring program, accessible via the license purchase of the questionnaire, will be used to analyze this questionnaire by giving a ponderation to each item to result in two different dimension scores.

Time frame: baseline

SF12 outcome at 3 months

Time frame: from baseline to 3 months after baseline

SF12 outcome at baseline at 6 months

Time frame: from baseline to 6 months

Persitence outcomes at 3 months

proportion of patients with ongoing Structum® at 3 months

Time frame: from baseline to 3 months after baseline

Persitence outcomes at 6 months

proportion of patients with ongoing Structum® at 6 months

Time frame: from baseline to 6 months after baseline

Personal global assessment, after first dose of Structum®, at 3 months

Proportion of patients with a positive assessment of Structum®, as assessed by Structum® treatment satisfaction questionnaire

Time frame: from baseline to 3 months after baseline

Personal global assessment, after first dose of Structum®, at 6 months

Proportion of patients with a positive assessment of Structum®, as assessed by Structum® treatment satisfaction questionnaire

Time frame: from baseline to 6 months after baseline