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An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)

30. april 2016 opdateret af: Hoffmann-La Roche

Rheumatoid Arthritis Patients Treated With Tocilizumab in Real Clinical Practice: Effectiveness and Safety (TRUST Study)

This observational study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis. Data will be collected from patients for the 12 months following the first infusion of RoActemra/Actemra.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

322

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • Abruzzo
      • Coppito, Abruzzo, Italien, 67100
      • Pescara, Abruzzo, Italien, 65100
    • Calabria
      • Reggio Calabria, Calabria, Italien, 89133
    • Campania
      • Avellino, Campania, Italien, 83100
      • Gragnano, Campania, Italien, 80054
      • Napoli, Campania, Italien, 80131
      • Napoli, Campania, Italien, 80138
      • Napoli, Campania, Italien, 80144
      • Salerno, Campania, Italien, 84131
      • Telese Terme, Campania, Italien, 82037
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40138
      • Ferrara, Emilia-Romagna, Italien, 44100
      • Modena, Emilia-Romagna, Italien, 41100
      • Piacenza, Emilia-Romagna, Italien, 29100
    • Friuli-Venezia Giulia
      • Trieste, Friuli-Venezia Giulia, Italien, 34142
    • Lazio
      • Albano Laziale, Lazio, Italien, 00041
      • Roma, Lazio, Italien, 00168
      • Roma, Lazio, Italien, 00152
      • Roma, Lazio, Italien, 00189
      • Roma, Lazio, Italien, 00128
      • Roma, Lazio, Italien, 00145
      • Viterbo, Lazio, Italien, 01100
    • Liguria
      • Arenzano, Liguria, Italien, 16011
    • Lombardia
      • Castel Goffredo, Lombardia, Italien, 46042
      • Gavardo, Lombardia, Italien, 25085
      • Legnano, Lombardia, Italien, 20025
      • Milano, Lombardia, Italien, 20157
      • Monza, Lombardia, Italien, 20052
      • Pavia, Lombardia, Italien, 27100
      • Rozzano, Lombardia, Italien, 20089
      • Saronno, Lombardia, Italien, 21047
      • Treviglio, Lombardia, Italien, 24047
      • Vimercate, Lombardia, Italien, 20059
    • Marche
      • Ancona, Marche, Italien, 60020
      • Jesi, Marche, Italien, 60035
    • Molise
      • Agnone, Molise, Italien, 86081
    • Piemonte
      • Cuneo, Piemonte, Italien, 12100
      • Novara, Piemonte, Italien, 28100
      • Torino, Piemonte, Italien, 10126
    • Puglia
      • Brindisi, Puglia, Italien, 72100
      • Casarano (LE), Puglia, Italien, 73042
      • Foggia, Puglia, Italien, 71100
      • Martina Franca, Puglia, Italien, 74015
      • San Cesario Di Lecce, Puglia, Italien, 73016
    • Sardegna
      • Sassari, Sardegna, Italien, 07100
    • Sicilia
      • Catania, Sicilia, Italien, 95124
      • Gazzi, Sicilia, Italien, 98125
      • Palermo, Sicilia, Italien, 90127
      • Palermo, Sicilia, Italien, 90146
    • Toscana
      • Firenze, Toscana, Italien, 50139
      • Massa, Toscana, Italien, 54100
      • Pisa, Toscana, Italien, 56100
      • Prato, Toscana, Italien, 59100
    • Umbria
      • Perugia, Umbria, Italien, 06122
    • Veneto
      • Verona, Veneto, Italien, 37126
      • Verona, Veneto, Italien, 37134

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra

Beskrivelse

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria
  • Initiated on RoActemra/Actemra treatment according to the Summary of Product Characteristics not more than 6 months before opening of study center

Exclusion Criteria:

  • Current serious infection
  • Hypersensitivity to the active component or any of the excipients
  • Pregnant women

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Tocilizumab
Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra [Tocilizumab (TCZ)] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment
Tidsramme: Up to 12 months
Low disease activity is defined as a disease activity score based on 28 joint count (DAS28) score lesser or equal to (</=) 3.2. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. Erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) measurement, 4. Participant's judgement on his own overall health status expressed by a visual analogue scale (VAS). The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. Percentage of participants with low disease activity was reported.
Up to 12 months
Percentage of Participants Achieving Disease Remission After 6 Months of Treatment
Tidsramme: Up to 12 months
Disease remission is defined as a DAS28 score < 2.6. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. Percentage of participants with disease remission was reported.
Up to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab
Tidsramme: Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12
The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3.ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation.
Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12
Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab
Tidsramme: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
VAS for fatigue is a 100 mm scale for participant's assessment of their current level of fatigue. The '0 'mm corresponds to "no perception of fatigue," '100 mm' is the "maximum level of fatigue that may be perceived." Mean score of VAS fatigue in participants were reported.
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab
Tidsramme: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
The health assessment questionnaire (HAQ) is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, the participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score of minimum/maximum i.e., 0 (best) to 3 (worst).
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Number of Participants With Concomitant Medications
Tidsramme: Up to 12 months
Number of participants treated with at least one concomitant medication i.e., corticosteroid (Prednisone, Methyl prednisolone) was reported.
Up to 12 months
Percentage of Participants Discontinuing Treatment With Tocilizumab
Tidsramme: Up to 12 months
The percentage of participants who prematurely discontinued treatment with TCZ during the study period was reported.
Up to 12 months
Number of Participants With Any Adverse Events and Serious Adverse Events
Tidsramme: Up to 12 months
An adverse event (AE) was defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Up to 12 months
Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion
Tidsramme: Up to 12 months
Percentage of participants who continued treatment till 12 months after the first infusion with TCZ was reported.
Up to 12 months
Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand.
Tidsramme: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
The presence and severity of synovial hyperplasia (SH) and joint effusion (JE) of second metacarpo-phalangeal (MCP) joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, synovial hyperplasia and joint effusion were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra articular surface).
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand.
Tidsramme: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
The presence and severity of SH and JE of third MCP joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of right hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intraarticular surface).
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand
Tidsramme: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
The presence and severity of SH and JE of second MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of second MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand.
Tidsramme: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
The presence and severity of SH and JE of third MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents
Tidsramme: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
The DAS28 index applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints) 3. ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. The mean DAS28 scores were evaluated after the first infusion of TCZ in two different sub populations: participants with inadequate response (IR) to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of DAS28 was available for 81 participants in DMARD-IR group and 203 participants in DMARD + anti-TNF-IR group.
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents
Tidsramme: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
VAS for fatigue is a 100 mm scale for participant's assessment of their current level of fatigue: 0 mm corresponds to "no perception of fatigue"; 100 mm is the "maximum that may be perceived". The mean VAS fatigue scores were evaluated after the first infusion of TCZ in two different sub populations, classified according to the previous pharmacological treatment: participants with inadequate response to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of fatigue (VAS) was available for 45 participants in DMARD-IR group and 113 participants in DMARD + anti-TNF-IR group.
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents
Tidsramme: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
The HAQ is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). Data allowing the evaluation of HAQ was available for 73 participants in DMARD-IR group and 157 participants in DMARD + anti-TNF-IR group.
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2011

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

13. juli 2011

Først indsendt, der opfyldte QC-kriterier

13. juli 2011

Først opslået (Skøn)

14. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML25728

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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