이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

2016년 1월 12일 업데이트: Hoffmann-La Roche

A Global Comparative Observational Study In Rheumatoid Arthritis (RA) Patients Who Are Treated With A TNF Inhibitor Or Tocilizumab As The First Biologic Therapy

This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.

연구 개요

상태

완전한

정황

연구 유형

관찰

등록 (실제)

1225

연락처 및 위치

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

연구 장소

  • 과테말라
      • Ciudad de Guatemala, 과테말라
  • 그리스
      • Athens, 그리스, 11527
      • Athens, 그리스, 155 62
      • Patra, 그리스, 26335
      • Thessaloniki, 그리스, 56429
      • Thessaloniki, 그리스, 544 65
  • 독일
      • Aachen, 독일, 52064
      • Bad Aibling, 독일, 83043
      • Bad Neuenahr-Ahrweiler, 독일, 53474
      • Bayreuth, 독일, 95445
      • Berlin, 독일, 13055
      • Dresden, 독일, 01109
      • Erfurt, 독일, 99096
      • Erlangen, 독일, 91056
      • Fulda, 독일, 36043
      • Hamburg, 독일, 22767
      • Hamburg, 독일, 22147
      • Heidelberg, 독일, 69121
      • Herne, 독일, 44652
      • Köln, 독일, 50937
      • Ludwigsfelde, 독일, 14974
      • München, 독일, 81541
      • München, 독일, 80639
      • Passau, 독일, 94032
      • Rostock, 독일, 18059
      • Stuttgart, 독일, 70178
      • Traunstein, 독일, 83278
      • Wuppertal, 독일, 42105
  • 멕시코
      • Guadalajara, 멕시코, 44650
      • Guadalajara, 멕시코, 44600
      • Guadalajara, 멕시코, 45040
      • Mexicali, 멕시코, 21100
      • Mexico Ctiy, 멕시코, 07760
  • 벨기에
      • AYE, 벨기에, 6900
      • Aalst, 벨기에, 9300
      • Assebroek, 벨기에, 8310
      • Bruxelles, 벨기에, 1050
      • Bruxelles, 벨기에, 1000
      • Edegem, 벨기에, 2650
      • Genk, 벨기에, 3600
      • Gent, 벨기에, 9000
      • Godinne, 벨기에, 5530
      • Heusy, 벨기에, 4802
      • Liège, 벨기에, 4000
      • Oostende, 벨기에, 8400
      • Verviers, 벨기에, 4800
      • Westmalle, 벨기에, 2390
  • 스위스
      • Aarau, 스위스, 5000
      • Basel, 스위스, 4031
      • Chur, 스위스, 7000
      • St. Gallen, 스위스, 9007
  • 스페인
      • Madrid, 스페인, 28006
      • Madrid, 스페인, 28905
      • Madrid, 스페인, 28007
    • Madrid
      • Fuenlabrada, Madrid, 스페인, 28942
      • San Sebastian de los Reyes, Madrid, 스페인, 28702
  • 아르헨티나
      • Catamarca Capital, 아르헨티나, 4700
      • Mendoza, 아르헨티나, 5500
      • Mendoza, 아르헨티나, 5501
      • Rosario, 아르헨티나, S2000PBJ
  • 에콰도르
      • Cuenca, 에콰도르
      • Esmeraldas, 에콰도르, EC080150
      • Guayaquil, 에콰도르, EC090114
      • Portoviejo, 에콰도르
      • Quito, 에콰도르, 005932
      • Quito, 에콰도르, EC170135
      • Quito, 에콰도르, EC170412
  • 영국
      • Barnsley, 영국, S75 2EP
      • Basildon, 영국, SS16 5NL
      • Basingstoke, 영국, RG24 9NA
      • Brighton, 영국, BN2 5BE
      • Cannock, 영국, WS11 5XY
      • Cardiff, 영국, CF14 4XW
      • Chertsey, 영국, KT16 0PZ
      • Crawley, 영국, RH11 7DH
      • Darlington, 영국, DL3 6HX
      • Enfield, 영국, EN2 8JL
      • Grimsby, 영국, DN33 2BA
      • Guildford, 영국, GU2 7XX
      • Ipswich, 영국, IP4 5PD
      • Kettering, 영국, NN16 8UZ
      • Lancaster, 영국, LA1 4RP
      • Leeds, 영국, LS7 4SA
      • Llandudno, 영국, LL30 1LB
      • London, 영국, W6 8RF
      • London, 영국, SW17 0QT
      • London, 영국, SE18 4QH
      • Luton, 영국, LU4 0DZ
      • Maidstone, 영국, ME16 9QQ
      • Margate, 영국, CT9 4AN
      • North Shields, 영국, NE29 8NH
      • Oswestry, 영국, SY10 7AG
      • Plymouth, 영국, PL6 8DH
      • Portsmouth, 영국, PO6 3LY
      • Reading, 영국, RG1 5AN
      • Rhyl, 영국, LL18 5UJ
      • Romford, 영국, RM7 0AG
      • Sheffield, 영국, S10 2JF
      • Stockport, 영국, SK2 7JE
      • Sunderland, 영국, SR4 7TP
      • Swindon, 영국, SN3 6BB
      • Torquay, 영국, TQ2 7AA
      • Warrington, 영국, WA5 1QG
      • Wirral, 영국, CH49 5PE
      • Wolverhampton, 영국, WV10 0QP
      • Wrightington, 영국, WN6 9EP
  • 우루과이
      • Montevideo, 우루과이, 11000
      • Montevideo, 우루과이, 11800
  • 우크라이나
      • Donetsk, 우크라이나, 83045
      • Kharkiv, 우크라이나, 61052
      • Kmelnytskyy, 우크라이나, 29000
      • Kyiv, 우크라이나, 02125
      • Kyiv, 우크라이나, 03151
      • Kyiv, 우크라이나, 1023
      • Odesa, 우크라이나, 65026
      • Uzhgorod, 우크라이나, 88000
      • Zaporizhzhya, 우크라이나, 69600
  • 이탈리아
    • Abruzzo
      • Coppito, Abruzzo, 이탈리아, 67100
      • Pescara, Abruzzo, 이탈리아, 65100
    • Calabria
      • Reggio Calabria, Calabria, 이탈리아, 89133
    • Campania
      • Avellino, Campania, 이탈리아, 83100
      • Napoli, Campania, 이탈리아, 80131
      • Napoli, Campania, 이탈리아, 80144
      • Salerno, Campania, 이탈리아, 84131
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, 이탈리아, 33100
    • Lazio
      • Roma, Lazio, 이탈리아, 00133
      • Roma, Lazio, 이탈리아, 00189
    • Liguria
      • Arenzano, Liguria, 이탈리아, 16011
    • Lombardia
      • Brescia, Lombardia, 이탈리아, 25123
      • Legnano, Lombardia, 이탈리아, 20025
      • Milano, Lombardia, 이탈리아, 20157
      • Milano, Lombardia, 이탈리아, 20162
    • Marche
      • Jesi Ancona, Marche, 이탈리아, 60035
    • Molise
      • Agnone, Molise, 이탈리아, 86081
    • Piemonte
      • Torino, Piemonte, 이탈리아, 10126
      • Torino, Piemonte, 이탈리아, 10128
    • Puglia
      • Brindisi, Puglia, 이탈리아, 72100
      • Martina Franca, Puglia, 이탈리아, 74015
      • San Cesario Di Lecce, Puglia, 이탈리아, 73016
    • Sicilia
      • Catania, Sicilia, 이탈리아, 95124
    • Toscana
      • Prato, Toscana, 이탈리아, 59100
    • Umbria
      • Perugia, Umbria, 이탈리아, 06122
  • 콜롬비아
      • Barranquilla, 콜롬비아
      • Bogota, 콜롬비아
      • Bucaramanga, 콜롬비아
      • Medellin, 콜롬비아
  • 파나마
      • Panama City, 파나마, 32400
  • 포르투갈
      • Almada, 포르투갈, 2801-951
      • Amadora, 포르투갈, 2720-276
      • Lisboa, 포르투갈, 1649-035
      • Lisboa, 포르투갈, 1069-166
      • Porto, 포르투갈, 4200-319
      • Porto, 포르투갈, 4099-001
      • Vila Nova de Gaia, 포르투갈, 4400-129

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

Adult patients with rheumatoid arthritis

설명

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of rheumatoid arthritis
  • Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
  • Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed

Exclusion Criteria:

  • Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
  • Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
  • Patients whose first biologic is rituximab, abatacept or anakinra.
  • Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
보병대

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
기간: Baseline and Week 24
Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker [erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (</=) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Week 24

2차 결과 측정

결과 측정
측정값 설명
기간
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
기간: Baseline and Week 52
Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Week 52
Mean Change From Baseline in Erythrocyte Sedimentation Rate
기간: Baseline, Week 24, Week 52
Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.
Baseline, Week 24, Week 52
Mean Change From Baseline in C-reactive Protein
기간: Baseline, Week 24, Week 52
Blood samples were collected for C-reactive protein (CRP). CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA.
Baseline, Week 24, Week 52
Mean Change From Baseline in Swollen Joint Count
기간: Baseline, Week 24, Week 52
A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28.
Baseline, Week 24, Week 52
Mean Change From Baseline in Tender Joint Count
기간: Baseline, Week 24, Week 52
A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.
Baseline, Week 24, Week 52
Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score
기간: Baseline, Week 24, Week 52
Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP. SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.
Baseline, Week 24, Week 52
Mean Change From Baseline in Physician Global Assessment Score
기간: Baseline, Week 24, Week 52
The Physician's Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). Change from baseline = scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline, Week 24, Week 52
Loss of Efficacy or Development of Intolerance to Biologic Therapy
기간: Up to Week 52
Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.
Up to Week 52
Proportion of Participants Who Terminated Biologic Treatment
기간: Up to Week 52
The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.
Up to Week 52
Reasons for Treatment Discontinuation
기간: Up to Week 52
The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.
Up to Week 52
Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period
기간: Up to end of treatment
The total number of participants who discontinued biologic therapy at the end of each study period (Week 0 - 24, Week 24 - 52, Week 52 - 57 and Week 57 - end of treatment) is presented. Participants who did not have a biologic therapy discontinuation or discontinued before having one, were considered as 'censored' at the date study termination.
Up to end of treatment
Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy
기간: Up to Week 52
An infusion reaction was defined as an adverse event (AE) occurring during and within 24 hours after the infusion, which may include hypersensitivity reactions or anaphylactic reactions. Injection site reactions were included in the summaries for infusion reactions.
Up to Week 52
Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events
기간: Up to Week 52
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 Week 52
Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study
기간: Up to Week 52
Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Based on seriousness criteria, they were categorized as serious and non-serious adverse events of special interest.
Up to Week 52
Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score
기간: Baseline, Week 24, Week 52
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
Baseline, Week 24, Week 52
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score
기간: Baseline, Week 24, Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.
Baseline, Week 24, Week 52
Mean Change From Baseline in Visual Analogue Scale Pain Score
기간: Baseline, Week 24, Week 52
VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from baseline =scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline, Week 24, Week 52
Shift From Baseline in Morning Stiffness
기간: Baseline, Week 24, Week 52
Shift tables presenting the number of participants in each bivariate category Week (W) 0 versus Week 24 and Week 52, with regards to morning stiffness at the different time points, was presented for each treatment arm. For participants who experienced joint stiffness while waking up in the morning, duration of morning stiffness was categorized as follows: Less than 30 minutes (min), Between 30 and 60 minutes, Between 60 and 120 minutes, Between 120 to 240 minutes, More than 240 minutes and the whole day. Baseline = BL
Baseline, Week 24, Week 52
Change From Baseline in Patient Global Assessment of Disease Activity
기간: Baseline, Week 24, Week 52
The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Baseline, Week 24, Week 52

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2012년 2월 1일

기본 완료 (실제)

2015년 2월 1일

연구 완료 (실제)

2015년 2월 1일

연구 등록 날짜

최초 제출

2012년 2월 28일

QC 기준을 충족하는 최초 제출

2012년 2월 28일

처음 게시됨 (추정)

2012년 3월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 2월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 1월 12일

마지막으로 확인됨

2016년 1월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MA27950

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. .

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유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Philippines

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다