Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

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

12 января 2016 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Тип исследования

Наблюдательный

Регистрация (Действительный)

1225

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Вероятностная выборка

Исследуемая популяция

Adult patients with rheumatoid arthritis

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Когорта

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Hoffmann-La Roche

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 февраля 2012 г.

Первичное завершение (Действительный)

1 февраля 2015 г.

Завершение исследования (Действительный)

1 февраля 2015 г.

Даты регистрации исследования

Первый отправленный

28 февраля 2012 г.

Впервые представлено, что соответствует критериям контроля качества

28 февраля 2012 г.

Первый опубликованный (Оценивать)

5 марта 2012 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

10 февраля 2016 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

12 января 2016 г.

Последняя проверка

1 января 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • MA27950

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться