Undersøgelse af Structum® hos voksne patienter med slidgigt (TRUST) (TRUST)
Prospektiv ikke-interventionel undersøgelse af Structum® hos voksne patienter med slidgigt
Chondroitinsulfat (CS) er en SYSADOA og et naturligt biomakromolekyle, der tilhører klassen af glycosaminoglycaner. CS er en vigtig bestanddel af den ekstracellulære matrix (ECM), hvor den udgør en væsentlig bestanddel af proteoglycaner.
Til dato er der ikke udført studier i den virkelige verden for præcist at beskrive byrden forbundet med OA blandt patienter behandlet med CS. Derfor vil der blive udført en observationel, beskrivende, prospektiv, national undersøgelse for at beskrive belastningen forbundet med OA og kvaliteten af livet for patienter behandlet med Structum® i Polen.
Studieoversigt
Detaljeret beskrivelse
Dette er en observationel, beskrivende, national, multicentrisk, prospektiv, longitudinel undersøgelse, som vil blive udført over en 6-måneders opfølgningsperiode for hver patient. Undersøgelsen vil ikke give eller anbefale nogen specifik behandling eller procedurer.
Alle patienter, der er ramt af OA i knæet, til hvem Structum® er ordineret i et deltagende center, vil blive screenet på en fortløbende måde for egnethed. Undersøgelsen vil udelukkende fokusere på patienter med OA i knæet, da dette er det led, der hyppigst rammes og lettest vurderes for OA-patienter.
Der kan forventes to yderligere dataindsamlinger for disse patienter som en del af deres standardbehandlingsopfølgningsbesøg, som normalt vil finde sted omkring 3 og 6 måneder efter det indledende studiebesøg. Patientindskrivningsperioden forventes at være 6 måneder, med en samlet studietid på 12 måneder.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Bialystok, Polen, 15-481
- Maciej Dołżyński
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Bydgoszcz, Polen, 85-091
- Piotr Ligocki
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Katowice, Polen, 40-007
- Elżbieta Pietrus- Dunaszewska
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Krakow, Polen, 31-155
- Bartlomiej Szpyra
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Krakow, Polen, 31-455
- Alina Wołkowicz Mruk
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Kujakowice Gorn, Polen, 46-211
- Andrzej Majer
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Lubartów, Polen, 21-100
- Agnieska WIAK
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Nowy Dwór Gdański, Polen, 82-100
- Wojciech Larczyński
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Olesno, Polen, 46-300
- Sławomir Panek
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Szczecin, Polen, 71-497
- Marcin Milchert
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Ustrzyki Dolne, Polen, Ustrzyki Dolne
- Wojciech Roczniak
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Warsaw, Polen, 03-938
- Zdzisław Derleta
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Zielona Góra, Polen, 65-047
- Michał Straburzyński
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Zielona Góra, Polen, 65-559
- Mariusz Borowiecki
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Żagań, Polen, 68-100
- Viktor Kostiuk
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- Mandlige eller kvindelige patienter i alderen 50 til 80 år ved inklusion
af knæ-OA (enten en patient, der er nyligt diagnosticeret [ved inklusion] eller med en historie med knæ-OA) baseret på mindst følgende punkter 1 og/eller 2:
- knæsmerter, der varer i mindst 3 måneder;
- patient i den aktive fase af knæ-OA-sygdom (knæsmerterscore ≥ 40 mm ved inklusion på den visuelle analoge skala [VAS] 0-100 mm);
- røntgenbilleder af knæ, der viser knæledsforsnævring og/eller osteofytter.
- Patienter, der for første gang eller ej har fået ordineret Structum®.
- Hvis patienten tager NSAID'er eller andre analgetika, kan patienten have en stabil dosis mindst en uge før optagelse i undersøgelsen.
- Patienter i stand til at besøge klinikken og deltage i opfølgningsbesøg.
- Patienter, der har underskrevet en informeret samtykkeerklæring i henhold til lokale regler.
Ekskluderingskriterier:
- Patienter med enhver igangværende behandling med chondroitinsulfat ved inklusion eller i løbet af de sidste 3 måneder.
- plasma (i de sidste 3 måneder). Ingen indgift af glukokortikoider inden for de sidste 3 måneder før inklusion. Dette inkluderer ikke NSAIDS, paracetamol og andre smertestillende medicin (f.eks. tramadol).
- Patienter med et kunstigt knæled, herunder ensidigt.
- Patienter, der er planlagt til at gennemgå en udskiftningsoperation i knæet inden for de næste 6 måneder.
- Patienter med en alvorlig almentilstand, der forhindrer dem i at blive inkluderet i undersøgelsen som vurderet af investigator.
- Patienter, der deltager i interventionelle forsøg med forsøgsmedicin på tidspunktet for inklusion.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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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
Tidsramme: At baseline (inclusion)
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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. |
At baseline (inclusion)
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Charlson Comorbidity Index Score Measured at Baseline
Tidsramme: At baseline (inclusion)
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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.
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At baseline (inclusion)
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Treatment History Received by the Patients in the Past 6 Months Before Inclusion
Tidsramme: From 6 months before inclusion to inclusion (baseline)
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Treatment history corresponds to the treatment received or not (yes/no) for knee osteoarthritis in the past 6 months before inclusion in the study
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From 6 months before inclusion to inclusion (baseline)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 3 Months
Tidsramme: From baseline (inclusion) to 3 months after baseline
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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. |
From baseline (inclusion) to 3 months after baseline
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 6-months
Tidsramme: From baseline to 6 months after baseline
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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. |
From baseline to 6 months after baseline
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BONe's Questionnaire at Baseline
Tidsramme: At baseline (inclusion)
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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.
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At baseline (inclusion)
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BONe's Outcome at 3 Months
Tidsramme: From baseline (inclusion) to 3 months after baseline
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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. |
From baseline (inclusion) to 3 months after baseline
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BONe's Outcome at 6 Months
Tidsramme: From baseline (inclusion) to 6 months after baseline
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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. |
From baseline (inclusion) to 6 months after baseline
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Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at Baseline
Tidsramme: At baseline (inclusion)
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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.
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At baseline (inclusion)
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Short Form Questionnaire With 12 Questions (SF-12) Outcome: Physical Score Component at 3 Months
Tidsramme: From baseline to 3 months after baseline
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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. |
From baseline to 3 months after baseline
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Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at 6 Months
Tidsramme: From baseline to 6 months after baseline
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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 |
From baseline to 6 months after baseline
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Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at Baseline
Tidsramme: Baseline
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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.
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Baseline
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Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at 3 Months
Tidsramme: From baseline to 3 months after baseline
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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. |
From baseline to 3 months after baseline
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Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at 6 Months
Tidsramme: From baseline to 6 months
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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.
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From baseline to 6 months
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Persistence Outcomes at 3 Months
Tidsramme: At 3 months after baseline
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Proportion of patients with ongoing Structum® prescription at 3 months
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At 3 months after baseline
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Persistence Outcomes at 6 Months
Tidsramme: At 6 months after baseline
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Proportion of patients with ongoing Structum® prescription at 6 months
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At 6 months after baseline
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Global Score of Patients Satisfaction, After First Dose of Structum®, at 3 Months
Tidsramme: At 3 months after baseline
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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.
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At 3 months after baseline
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Global Score of Patient Satisfaction, After First Dose of Structum®, at 6 Months
Tidsramme: At 6 months after baseline
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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.
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At 6 months after baseline
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Spearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the Short Form Questionnaire, SF-12 Questionnaire (Physical and Mental Component) at Inclusion.
Tidsramme: Baseline (inclusion)
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The interpretation of the correlation coefficient is as follows: <0.5: weak correlation 0.5-0.6: mild correlation 0.6-0.7: moderate correlation >0.7: strong correlation Of note, values of the coefficient could be positive or negative |
Baseline (inclusion)
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Spearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the SF-12 Questionnaire (Physical and Mental Components) at 3 Months
Tidsramme: At 3 months after baseline
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At 3 months after baseline
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Spearman Correlation Coefficient for the Correlation Between the BONe'S Questionnaire and the Short Form, SF-12 Questionnaire at 6 Months.
Tidsramme: At 6 months after baseline
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The interpretation of the correlation coefficient is as follows: <0.5: weak correlation 0.5-0.6: mild correlation 0.6-0.7: moderate correlation >0.7: strong correlation |
At 6 months after baseline
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Spearman Correlation Coefficient for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at Inclusion
Tidsramme: Baseline (inclusion)
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The interpretation of the correlation coefficient is as follows: <0.5: weak correlation 0.5-0.6: mild correlation 0.6-0.7: moderate correlation >0.7: strong correlation |
Baseline (inclusion)
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Spearman Correlation Coefficient and P Value for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at 3 Months
Tidsramme: At 3 months after baseline
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The interpretation of the correlation coefficient is as follows: <0.5: weak correlation 0.5-0.6: mild correlation 0.6-0.7: moderate correlation >0.7: strong correlation |
At 3 months after baseline
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Spearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at 6 Months.
Tidsramme: At 6 months after baseline
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The interpretation of the correlation coefficient is as follows: <0.5: weak correlation 0.5-0.6: mild correlation 0.6-0.7: moderate correlation >0.7: strong correlation |
At 6 months after baseline
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Change in NSAIDs and Other Analgesics at Inclusion Compared to 6 Months Before Inclusion
Tidsramme: Baseline (inclusion)
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Description of the proportion of patients with a change in their prescription of NSAIDs and other analgesics at inclusion, compared to 6 months before inclusion, with a change being defined as any change of the daily dose of NSAIDs (calculated from the frequency of intake and the dose of each intake)
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Baseline (inclusion)
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Changes in NSAIDs and Other Analgesics at 3 Months Compared to Inclusion
Tidsramme: From baseline to 3 months after baseline
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Proportion of patients with changes in the prescription of NSAIDs and other analgesics at 3 months compared to inclusion
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From baseline to 3 months after baseline
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Change in NSAIDs and Other Analgesics at 6 Months Compared to Inclusion
Tidsramme: From baseline to 6 months after baseline
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Proportion of patients with changes in the prescription of NSAIDs and other analgesics at 6 months compared to inclusion
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From baseline to 6 months after baseline
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: PIOTR WILAND, Medical University of WROCLAW
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIS13559
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Data vil blive indsamlet og opbevaret i et pseudonymiseret format uden direkte identificerende værdier, der kan forbinde dataene med den tilsvarende deltager i undersøgelsen.
Investigator skal sikre, at patientens fortrolighed opretholdes. Det er påkrævet, at efterforskeren og institutionen tillader autoriserede repræsentanter for sponsoren, for tilsynsmyndighederne og de institutionelle EC'er direkte adgang til at gennemgå patientens originale lægejournaler til verifikation af undersøgelsesrelaterede procedurer og data. Direkte adgang omfatter at undersøge, analysere, verificere og gengive alle optegnelser og rapporter, der er vigtige for evalueringen af undersøgelsen.
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