An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)
30 de abril de 2016 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
322
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Abruzzo
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Coppito, Abruzzo, Itália, 67100
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Pescara, Abruzzo, Itália, 65100
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Calabria
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Reggio Calabria, Calabria, Itália, 89133
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Campania
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Avellino, Campania, Itália, 83100
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Gragnano, Campania, Itália, 80054
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Napoli, Campania, Itália, 80131
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Napoli, Campania, Itália, 80138
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Napoli, Campania, Itália, 80144
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Salerno, Campania, Itália, 84131
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Telese Terme, Campania, Itália, 82037
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Emilia-Romagna
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Bologna, Emilia-Romagna, Itália, 40138
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Ferrara, Emilia-Romagna, Itália, 44100
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Modena, Emilia-Romagna, Itália, 41100
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Piacenza, Emilia-Romagna, Itália, 29100
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Friuli-Venezia Giulia
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Trieste, Friuli-Venezia Giulia, Itália, 34142
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Lazio
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Albano Laziale, Lazio, Itália, 00041
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Roma, Lazio, Itália, 00168
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Roma, Lazio, Itália, 00152
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Roma, Lazio, Itália, 00189
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Roma, Lazio, Itália, 00128
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Roma, Lazio, Itália, 00145
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Viterbo, Lazio, Itália, 01100
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Liguria
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Arenzano, Liguria, Itália, 16011
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Lombardia
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Castel Goffredo, Lombardia, Itália, 46042
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Gavardo, Lombardia, Itália, 25085
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Legnano, Lombardia, Itália, 20025
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Milano, Lombardia, Itália, 20157
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Monza, Lombardia, Itália, 20052
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Pavia, Lombardia, Itália, 27100
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Rozzano, Lombardia, Itália, 20089
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Saronno, Lombardia, Itália, 21047
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Treviglio, Lombardia, Itália, 24047
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Vimercate, Lombardia, Itália, 20059
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Marche
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Ancona, Marche, Itália, 60020
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Jesi, Marche, Itália, 60035
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Molise
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Agnone, Molise, Itália, 86081
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Piemonte
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Cuneo, Piemonte, Itália, 12100
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Novara, Piemonte, Itália, 28100
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Torino, Piemonte, Itália, 10126
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Puglia
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Brindisi, Puglia, Itália, 72100
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Casarano (LE), Puglia, Itália, 73042
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Foggia, Puglia, Itália, 71100
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Martina Franca, Puglia, Itália, 74015
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San Cesario Di Lecce, Puglia, Itália, 73016
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Sardegna
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Sassari, Sardegna, Itália, 07100
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Sicilia
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Catania, Sicilia, Itália, 95124
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Gazzi, Sicilia, Itália, 98125
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Palermo, Sicilia, Itália, 90127
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Palermo, Sicilia, Itália, 90146
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Toscana
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Firenze, Toscana, Itália, 50139
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Massa, Toscana, Itália, 54100
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Pisa, Toscana, Itália, 56100
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Prato, Toscana, Itália, 59100
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Umbria
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Perugia, Umbria, Itália, 06122
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Veneto
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Verona, Veneto, Itália, 37126
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Verona, Veneto, Itália, 37134
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment
Prazo: Up to 12 months
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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.
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Up to 12 months
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Percentage of Participants Achieving Disease Remission After 6 Months of Treatment
Prazo: Up to 12 months
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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.
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Up to 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab
Prazo: Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12
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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.
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Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12
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Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab
Prazo: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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.
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Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab
Prazo: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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).
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Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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Number of Participants With Concomitant Medications
Prazo: Up to 12 months
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Number of participants treated with at least one concomitant medication i.e., corticosteroid (Prednisone, Methyl prednisolone) was reported.
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Up to 12 months
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Percentage of Participants Discontinuing Treatment With Tocilizumab
Prazo: Up to 12 months
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The percentage of participants who prematurely discontinued treatment with TCZ during the study period was reported.
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Up to 12 months
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Number of Participants With Any Adverse Events and Serious Adverse Events
Prazo: Up to 12 months
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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.
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Up to 12 months
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Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion
Prazo: Up to 12 months
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Percentage of participants who continued treatment till 12 months after the first infusion with TCZ was reported.
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Up to 12 months
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Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand.
Prazo: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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).
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Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand.
Prazo: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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).
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Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand
Prazo: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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).
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Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand.
Prazo: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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).
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Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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
Prazo: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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.
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Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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
Prazo: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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.
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Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents
Prazo: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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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.
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Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2011
Conclusão Primária (Real)
1 de abril de 2013
Conclusão do estudo (Real)
1 de abril de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
13 de julho de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de julho de 2011
Primeira postagem (Estimativa)
14 de julho de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
7 de junho de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de abril de 2016
Última verificação
1 de abril de 2016
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ML25728
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