An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)
2016年4月30日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
322
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Abruzzo
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Coppito、Abruzzo、イタリア、67100
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Pescara、Abruzzo、イタリア、65100
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Calabria
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Reggio Calabria、Calabria、イタリア、89133
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Campania
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Avellino、Campania、イタリア、83100
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Gragnano、Campania、イタリア、80054
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Napoli、Campania、イタリア、80131
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Napoli、Campania、イタリア、80138
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Napoli、Campania、イタリア、80144
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Salerno、Campania、イタリア、84131
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Telese Terme、Campania、イタリア、82037
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Emilia-Romagna
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Bologna、Emilia-Romagna、イタリア、40138
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Ferrara、Emilia-Romagna、イタリア、44100
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Modena、Emilia-Romagna、イタリア、41100
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Piacenza、Emilia-Romagna、イタリア、29100
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Friuli-Venezia Giulia
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Trieste、Friuli-Venezia Giulia、イタリア、34142
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Lazio
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Albano Laziale、Lazio、イタリア、00041
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Roma、Lazio、イタリア、00168
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Roma、Lazio、イタリア、00152
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Roma、Lazio、イタリア、00189
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Roma、Lazio、イタリア、00128
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Roma、Lazio、イタリア、00145
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Viterbo、Lazio、イタリア、01100
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Liguria
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Arenzano、Liguria、イタリア、16011
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Lombardia
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Castel Goffredo、Lombardia、イタリア、46042
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Gavardo、Lombardia、イタリア、25085
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Legnano、Lombardia、イタリア、20025
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Milano、Lombardia、イタリア、20157
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Monza、Lombardia、イタリア、20052
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Pavia、Lombardia、イタリア、27100
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Rozzano、Lombardia、イタリア、20089
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Saronno、Lombardia、イタリア、21047
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Treviglio、Lombardia、イタリア、24047
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Vimercate、Lombardia、イタリア、20059
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Marche
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Ancona、Marche、イタリア、60020
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Jesi、Marche、イタリア、60035
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Molise
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Agnone、Molise、イタリア、86081
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Piemonte
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Cuneo、Piemonte、イタリア、12100
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Novara、Piemonte、イタリア、28100
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Torino、Piemonte、イタリア、10126
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Puglia
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Brindisi、Puglia、イタリア、72100
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Casarano (LE)、Puglia、イタリア、73042
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Foggia、Puglia、イタリア、71100
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Martina Franca、Puglia、イタリア、74015
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San Cesario Di Lecce、Puglia、イタリア、73016
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Sardegna
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Sassari、Sardegna、イタリア、07100
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Sicilia
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Catania、Sicilia、イタリア、95124
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Gazzi、Sicilia、イタリア、98125
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Palermo、Sicilia、イタリア、90127
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Palermo、Sicilia、イタリア、90146
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Toscana
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Firenze、Toscana、イタリア、50139
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Massa、Toscana、イタリア、54100
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Pisa、Toscana、イタリア、56100
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Prato、Toscana、イタリア、59100
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Umbria
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Perugia、Umbria、イタリア、06122
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Veneto
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Verona、Veneto、イタリア、37126
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Verona、Veneto、イタリア、37134
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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).
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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
時間枠：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).
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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.
時間枠：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).
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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
時間枠：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
時間枠：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
時間枠：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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年5月1日
一次修了 (実際)
2013年4月1日
研究の完了 (実際)
2013年4月1日
試験登録日
最初に提出
2011年7月13日
QC基準を満たした最初の提出物
2011年7月13日
最初の投稿 (見積もり)
2011年7月14日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年6月7日
QC基準を満たした最後の更新が送信されました
2016年4月30日
最終確認日
2016年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。