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A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy

30 августа 2018 г. обновлено: Hoffmann-La Roche

Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy

This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid arthritis. Eligible participants initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Наблюдательный

Регистрация (Действительный)

71

Контакты и местонахождение

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

Места учебы

  • Бельгия
      • Aalst, Бельгия, 9300
        • ASZ Aalst
      • Ath, Бельгия, 7800
        • CH EpiCURA Site Ath
      • Bruxelles, Бельгия, 1020
        • CHU Brugmann (Victor Horta)
      • Bruxelles, Бельгия, 1070
        • Hospital Erasme; Neurologie
      • Genk, Бельгия, 3600
        • ReumaClinic
      • Gilly (Charleroi), Бельгия, 6000
        • GHdC Site Saint-Joseph
      • Gosselies, Бельгия, 6041
        • Clinique Notre Dame de Grâce
      • Haine-Saint-Paul, Бельгия, 7100
        • CH Jolimont - Lobbes (Jolimont)
      • Kortrijk, Бельгия, 8500
        • AZ Groeninge
      • Liège, Бельгия, 4000
        • CHR de la Citadelle
      • Liège, Бельгия, 4000
        • Clinique Saint-Joseph
      • Mons, Бельгия, 7000
        • CHU Ambroise Paré
      • Oostende, Бельгия, 8400
        • AZ Damiaan
      • Ottignies, Бельгия, 1340
        • Clinique St Pierre asbl
      • Roeselare, Бельгия, 8800
        • AZ Delta (Campus Wilgenstraat)
      • Turnhout, Бельгия, 2300
        • AZ Turnhout Sint Jozef
      • Wilrijk, Бельгия, 2610
        • Sint Augustinus Wilrijk

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

Participants with rheumatoid arthritis initiating treatment with RoActemra/Actemra in monotherapy

Описание

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
  • Concomitant treatment with NSAIDs and/or corticosteroids is allowed

Exclusion Criteria:

  • Participants who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
  • Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
  • Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study
  • Participants who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

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
Вмешательство/лечение
Tocilizumab
Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Лекарство: tocilizumab
Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Другие имена:
  • Актемра

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Временное ограничение
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
Временное ограничение: Month 6 after treatment initiation
Month 6 after treatment initiation

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants With Systemic Manifestations of RA at Baseline
Временное ограничение: Baseline
Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least any one of the conditions.
Baseline
Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response
Временное ограничение: Baseline
Baseline
Number of Participants With Inadequate Response to Other Biologics
Временное ограничение: Baseline
Baseline
Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)
Временное ограничение: Month 6
The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.
Month 6
Percentage of Participants Who Had DMARDs During Study
Временное ограничение: Month 6
Month 6
Number of Participants With Dose Reductions
Временное ограничение: 6 months
6 months
Number of Participants With Starting Tocilizumab After Failing DMARDs
Временное ограничение: Baseline
Baseline
Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents
Временное ограничение: Baseline
Baseline
Time to Reduction/Withdrawal of Corticosteroids
Временное ограничение: Month 6
Month 6
Number of Dose Modifications Per Participant at Month 6
Временное ограничение: Month 6
Number of dose modification per participant at Month 6 was reported.
Month 6
Mean Dosing Interval Per Participant at Month 6
Временное ограничение: Month 6
Month 6
Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy
Временное ограничение: Month 6
Month 6
Time for Restoration of Initial Dosing Regimen
Временное ограничение: Month 6
Month 6
Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen
Временное ограничение: Month 6
Month 6
Number of Participants Who Were Not Adhering to Recommended Management of AEs
Временное ограничение: Month 6
Month 6
Percentage of Participants Still on Tocilizumab Monotherapy at Month 6
Временное ограничение: Month 6
Month 6
Percentage of Participants With Reason for Choice of Monotherapy at Baseline
Временное ограничение: Baseline
Baseline
Tender Joint Count (TJC)
Временное ограничение: Baseline, Month 3, 6
TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1.
Baseline, Month 3, 6
Swollen Joint Count (SJC)
Временное ограничение: Baseline, Month 3, 6
SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
Baseline, Month 3, 6
Percentage of Participants With Disease Activity Score-28 (DAS28)
Временное ограничение: Baseline, Month 3, 6
DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.
Baseline, Month 3, 6
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Временное ограничение: Month 3, 6
Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement.
Month 3, 6
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6
Временное ограничение: Month 3, 6
ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.
Month 3, 6
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response
Временное ограничение: Baseline, Month 3, 6
CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.
Baseline, Month 3, 6
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response
Временное ограничение: Baseline, Month 3, 6
The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.
Baseline, Month 3, 6
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6
Временное ограничение: Baseline, Month 3, 6
The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.
Baseline, Month 3, 6
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6
Временное ограничение: Baseline, Month 3, 6
The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. 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, Month 3, 6
Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6
Временное ограничение: Baseline, Month 3, 6
The HAQ was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.
Baseline, Month 3, 6
Change From Baseline in VAS-Fatigue at Month 3 and Month 6
Временное ограничение: Baseline, Month 3, 6
The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.
Baseline, Month 3, 6
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6
Временное ограничение: Baseline, Month 3, 6
The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.
Baseline, Month 3, 6
Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6
Временное ограничение: Baseline, Month 3, 6
Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.
Baseline, Month 3, 6
Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)
Временное ограничение: Month 6
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.
Month 6
Percentage of Participants With AEs Leading to Dose Modifications
Временное ограничение: Month 6
Month 6
C-reactive Protein (CRP]) Level
Временное ограничение: Baseline, Month 3, 6
CRP is an acute phase reactant and is a measure of inflammation.
Baseline, Month 3, 6
Erythrocyte Sedimentation Rate (ESR) Level
Временное ограничение: Baseline, Month 3, 6
ESR is an acute phase reactant and is a measure of inflammation.
Baseline, Month 3, 6

Соавторы и исследователи

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

Спонсор

Hoffmann-La Roche

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 (Действительный)

31 июля 2012 г.

Первичное завершение (Действительный)

12 декабря 2014 г.

Завершение исследования (Действительный)

12 декабря 2014 г.

Даты регистрации исследования

Первый отправленный

10 октября 2012 г.

Впервые представлено, что соответствует критериям контроля качества

10 октября 2012 г.

Первый опубликованный (Оценивать)

12 октября 2012 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

4 сентября 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

30 августа 2018 г.

Последняя проверка

1 августа 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • ML28269

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. .

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