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Tracking Biologics Along the Silk Road (HARIR)

9 января 2019 г. обновлено: Janssen Pharmaceutica N.V., Belgium

The objective of this study is to explore and describe the disease characteristics, treatment and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia.

Обзор исследования

Статус

Завершенный

Условия

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Colitis, Ulcerative

Тип исследования

Наблюдательный

Регистрация (Действительный)

140

Контакты и местонахождение

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

Места учебы

Алжир
- - Alger, Алжир
Египет
- - Alexandria, Египет
  - Cairo, Египет
Катар
- - Doha, Катар
Кувейт
- - Hawalli Area, Кувейт
  - Kuwait, Кувейт
Саудовская Аравия
- - Makkah, Саудовская Аравия
  - Riyadh, Саудовская Аравия

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

От 18 лет до 65 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

Participants with confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease, or ulcerative colitis as their major disease for which they will be treated with REMICADE, SIMPONI, or STELARA within clinical practice.

Описание

Inclusion Criteria:

Participant must have a confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease, or ulcerative colitis. A participant can be included for one disease only; participants with multiple diagnoses should be included for their major disease only
Initiation of treatment with REMICADE, SIMPONI, or STELARA should be planned at the time of enrollment into this observational study (such treatment should be started within 30 days of enrollment)
Participant must be either treatment-naïve to biologics or have been treated with no more than 2 different biologic agents before enrollment
Participant must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

Participant who have previously received treatment with REMICADE, SIMPONI, or STELARA must not be enrolled if they start the same therapy a second time
Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before baseline data collection
Participant is currently enrolled in an investigational study

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

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
Cohort 1: Rheumatoid Arthritis Participants with Rheumatoid arthritis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
Cohort 2: Ankylosing Spondylitis Participants with Ankylosing spondylitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
Cohort 3: Psoriatic Arthritis Participants with Psoriatic arthritis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
Cohort 4: Crohn's Disease Participants with Crohn's disease as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.
Cohort 5: Ulcerative Colitis Participants with Ulcerative colitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia will be observed for disease characteristics, treatment and outcomes.

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response Временное ограничение: Year 2/early withdrawal	The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).	Year 2/early withdrawal
Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response Временное ограничение: Year 2/early withdrawal	The ACR 50 Response is defined as >=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.	Year 2/early withdrawal
Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response Временное ограничение: Year 2/early withdrawal	The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.	Year 2/early withdrawal
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Response Временное ограничение: Year 2/early withdrawal	The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20 percent improvement from baseline and an absolute change >= 10 units on a 0-10 scale (0=no disease activity; 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.	Year 2/early withdrawal
Percentage of Participants Achieving ASAS 40 Response Временное ограничение: Year 2/early withdrawal	The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation. The ASAS 40 = 40 percent improvement from baseline and an absolute change >= 20 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.	Year 2/early withdrawal
Percentage of Participants Achieving ASAS 5/6 Response Временное ограничение: Year 2/early withdrawal	ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20 percent improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain.	Year 2/early withdrawal
Number of Participants With Clinical Response as Assessed by Crohn's Disease Activity Index (CDAI) Временное ограничение: Year 2/early withdrawal	The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. Clinical response defined as reduction of greater than or equal to 70 points and/or 25 percent from baseline in CDAI.	Year 2/early withdrawal
Number of Participants With Clinical Remission as Assessed by CDAI Временное ограничение: Year 2/early withdrawal	The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. Remission will be defined as CDAI less than (<) 150 points.	Year 2/early withdrawal
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Crohn's Disease Временное ограничение: Baseline, Year 2/early withdrawal	The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases. Each question has graded responses from 1 (worst situation) to 7 (best situation). Total score ranges from 32 (worst) to 224 (best). Higher scores indicate better quality of life.	Baseline, Year 2/early withdrawal
Number of Participants With Clinical Response as Assessed by Mayo Score Временное ограничение: Year 2/early withdrawal	Clinical response is defined as a decrease from baseline in the Mayo score by greater than or equal to 30 percent and >= 3 points, and a decrease from baseline in the rectal bleeding sub score to 0 or 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 sub scores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe. Higher scores indicate worsening of the disease.	Year 2/early withdrawal
Number of Participants With Clinical Remission as Assessed by Mayo Score Временное ограничение: Year 2/early withdrawal	Clinical remission is defined as a Mayo score less than or equal to 2 points, with no individual sub score greater than 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 sub scores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe. Higher scores indicate worsening of the disease.	Year 2/early withdrawal
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Ulcerative Colitis Временное ограничение: Year 2/early withdrawal	The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases. Each question has graded responses from 1 (worst situation) to 7 (best situation). Total score ranges from 32 (worst) to 224 (best). Higher scores indicate better quality of life.	Year 2/early withdrawal

Соавторы и исследователи

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

Спонсор

Janssen Pharmaceutica N.V., Belgium

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)

4 февраля 2016 г.

Первичное завершение (Действительный)

1 декабря 2018 г.

Завершение исследования (Действительный)

1 декабря 2018 г.

Даты регистрации исследования

Первый отправленный

28 декабря 2016 г.

Впервые представлено, что соответствует критериям контроля качества

28 декабря 2016 г.

Первый опубликованный (Оценивать)

30 декабря 2016 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

10 января 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 января 2019 г.

Последняя проверка

1 января 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

CR106936
C0168ARA4017 (Другой идентификатор: Janssen Pharmaceutica N.V., Belgium)

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

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. .