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

2016년 4월 30일 업데이트: 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.

연구 개요

상태

완전한

정황

류마티스 관절염

연구 유형

관찰

등록 (실제)

322

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
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).

그룹/코호트

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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment 기간: 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 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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. 기간: 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. 기간: 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 기간: 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. 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 5월 1일

기본 완료 (실제)

2013년 4월 1일

연구 완료 (실제)

2013년 4월 1일

연구 등록 날짜

최초 제출

2011년 7월 13일

QC 기준을 충족하는 최초 제출

2011년 7월 13일

처음 게시됨 (추정)

2011년 7월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 6월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 4월 30일

마지막으로 확인됨

2016년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

ML25728

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .