TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF
15 сентября 2014 г. обновлено: Hoffmann-La Roche
Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO
This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF.
For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo.
After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks.
Methotrexate or DMARD therapy will be continued throughout study treatment.
Target sample size is >100.
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
103
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Amiens, Франция, 80054
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Amiens, Франция, 80094
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Bayonne, Франция, 64109
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Bois Guillaume, Франция, 76233
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Bordeaux, Франция, 33076
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Brest, Франция, 29609
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Cahors, Франция, 46005
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Chambray Les Tours, Франция, 37171
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Clermont-ferrand, Франция, 63003
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Echirolles, Франция, 38434
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La Roche Sur Yon, Франция, 85925
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Limoges, Франция, 87042
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Lyon, Франция, 69437
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Metz, Франция, 57077
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Nantes, Франция, 44035
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Orleans, Франция, 45000
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Paris, Франция, 75651
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Paris, Франция, 75679
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Paris, Франция, 75877
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Rennes, Франция, 35203
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St Priest En Jarez, Франция, 42277
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Toulouse, Франция, 31059
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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
Описание
Inclusion Criteria:
- adult patients >/= 18 years of age
- active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF
- on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose
- patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks
Exclusion Criteria:
- rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- functional class IV by ACR classification
- history of inflammatory joint disease other than RA
- previous treatment with cell-depleting therapies, abatacept or rituximab
- active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening
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
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 1
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single iv infusion 8 mg/kg
iv infusion 8mg/kg every 4 weeks for 11 months
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Плацебо Компаратор: 2
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однократное в/в вливание
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Экспериментальный: 3
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single iv infusion 8 mg/kg
iv infusion 8mg/kg every 4 weeks for 11 months
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4
Временное ограничение: Week 4
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HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity.
To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen.
Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.
Minimum score was 0, maximum score was 3. Relevant clinical improvement was defined as a reduction of at least 0.22 points in HAQ-DI.
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Week 4
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period
Временное ограничение: Baseline, Weeks 1 and 4
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Participants were asked to rate their assessment of disease activity using a visual analog scale (VAS) of 0 to 100 millimeters (mm), where 0 represented no symptoms and 100 represented severe symptoms.
Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
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Baseline, Weeks 1 and 4
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Patient Global Assessment of Disease Activity During the Open Treatment Period
Временное ограничение: Baseline, Weeks 12, 24, 36 and 48
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Participants were asked to rate their assessment of disease activity using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms.
Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
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Baseline, Weeks 12, 24, 36 and 48
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Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period
Временное ограничение: Baseline and Week 4
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Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms.
Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
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Baseline and Week 4
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Physician Global Assessment of Disease Activity During the Open Treatment Period
Временное ограничение: Baseline, Weeks 12, 24, 36, and 48
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Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms.
Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
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Baseline, Weeks 12, 24, 36, and 48
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Patient Global Assessment of Pain During the Double-Blind Treatment Period
Временное ограничение: Baseline and Week 4
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Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain.
Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
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Baseline and Week 4
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Patient Global Assessment of Pain During the Open Treatment Period
Временное ограничение: Baseline and Weeks 12, 24, 36, and 48
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Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain.
Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
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Baseline and Weeks 12, 24, 36, and 48
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Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound
Временное ограничение: Baseline, Weeks 1 and 4
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Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 metacarpal phalangeal [MCP; left and right] joints, 5 proximal interphalangeal [PIP; left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 metatarsal phalangeal [MTP; left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120.
A score of 0 indicated no damage and a score of 120 indicated most severe damage.
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. A negative change from baseline indicated improvement.
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Baseline, Weeks 1 and 4
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Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound
Временное ограничение: Baseline, Weeks 1 and 4
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Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease).
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Negative change from baseline indicated improvement.
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Baseline, Weeks 1 and 4
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Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound
Временное ограничение: Weeks 12, 24, and 48
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Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease).
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage (%) change from baseline.
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Weeks 12, 24, and 48
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Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound
Временное ограничение: Weeks 12, 24, and 48
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Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease).
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage change from baseline.
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Weeks 12, 24, and 48
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Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period
Временное ограничение: Baseline, Weeks 1 and 4
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Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm per hour (mm/hr).
A reduction in ESR indicates improvement.
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Baseline, Weeks 1 and 4
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Percent Change From Baseline in Erythrocyte Sedimentation Rate During the Double-Blind Treatment
Временное ограничение: Weeks 1 and 4
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Erythrocyte sedimentation rate is a biological marker of inflammation.
A negative change indicates improvement.
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Weeks 1 and 4
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Erythrocyte Sedimentation Rate During the Open Treatment Period
Временное ограничение: Baseline, Weeks 12, 24, 36, and 48
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Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm/hr.
A reduction in ESR indicates improvement.
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Baseline, Weeks 12, 24, 36, and 48
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C-Reactive Protein During the Double-Blind Treatment Period
Временное ограничение: Baseline, Weeks 1 and 4
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C-Reactive protein (CRP) is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL).
A reduction in CRP indicates improvement.
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Baseline, Weeks 1 and 4
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Percent Change From Baseline in C-Reactive Protein During the Double-Blind Treatment Period
Временное ограничение: Weeks 1 and 4
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C-Reactive protein (CRP) is a biological marker of inflammation.
Negative changes from baseline indicate improvement.
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Weeks 1 and 4
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C- Reactive Protein During the Open Treatment Period
Временное ограничение: Baseline, Weeks 12, 24, 36, and 48
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C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL).
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Baseline, Weeks 12, 24, 36, and 48
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Serum Amyloid A Component During the Double-Blind Treatment Period
Временное ограничение: Baseline, Weeks 1 and 4
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Serum Amyloid A (SAA) component is a biological marker of inflammation and is measured in mg/L.
A reduction in SAA indicates improvement.
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Baseline, Weeks 1 and 4
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Percent Change From Baseline in Serum Amyloid A Component During the Double-Blind Treatment Period
Временное ограничение: Weeks 1 and 4
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Serum Amyloid A (SAA) component is a biological marker of inflammation.
A negative change from baseline indicates improvement.
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Weeks 1 and 4
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Serum Amyloid A Component During the Open Treatment Period
Временное ограничение: Baseline, Weeks 12, 24, 36, and 48
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Serum Amyloid A (SAA) component is a biological marker of inflammation measured in mg/L.
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Baseline, Weeks 12, 24, 36, and 48
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Beta 2 Microglobulin Levels During the Open Treatment Period
Временное ограничение: Baseline, Weeks 12, 24, 36, and 48
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Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL).
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Baseline, Weeks 12, 24, 36, and 48
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Beta 2 Microglobulin Levels During the Double-Blind Treatment Period
Временное ограничение: Baseline, Weeks 1 and 4
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Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL).
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Baseline, Weeks 1 and 4
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Percent Change From Baseline in Beta 2 Microglobulin Levels During the Double-Blind Treatment Period
Временное ограничение: Weeks 1 and 4
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Beta 2 Microglobulin is a biological marker of inflammation.
If baseline value was equal to 0, it was replaced by 0.1 to calculate the change from baseline.
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Weeks 1 and 4
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Bone Mineral Density
Временное ограничение: Baseline and Week 48
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To describe bone mineral density (BMD), standardized values were calculated for lumbar spine, hip, femoral neck, and trochanter, taking into account the type of Dual energy X ray absorptiometry (DXA) used.
All DXA at baseline were taken into account (done from before screening to Week 8).
DXA at end of study were taken into account if they were done after at least 6 infusions of tocilizumab.
Values were measured in milligrams per square centimeter (mg/cm^2).
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Baseline and Week 48
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Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period
Временное ограничение: Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
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Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
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S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period
Временное ограничение: Baseline, Weeks 12, 24, and 48
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S-Sclerostin and P-Dkk1 are biological markers of bone and cartilage metabolism measured as picograms/milliliter (pg/mL).
Baseline is the closest value plus or minus (+/-) 1 month around the first tocilizumab infusion.
If values before and after the first infusion were eligible, the value before was taken into account.
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Baseline, Weeks 12, 24, and 48
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Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period
Временное ограничение: Baseline and Weeks 12, 24, and 48
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S-PIIINP, S-CTX-I, and S-PINP are biological markers of bone and cartilage metabolism.
Baseline is the closest value +/- 1 month around the first tocilizumab infusion.
If values before and after the first infusion were eligible, the value before was taken into account.
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Baseline and Weeks 12, 24, and 48
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Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period
Временное ограничение: Baseline and Weeks 12 and 48
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S-OGP is a biological marker of bone and cartilage metabolism measured as picomoles per liter (pmol/L).
Baseline is the closest value +/- 1 month around the first tocilizumab infusion.
If values before and after the first infusion were eligible, the value before was taken into account.
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Baseline and Weeks 12 and 48
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Weekly Methotrexate (MTX) Dose
Временное ограничение: Baseline and Weeks 24 and 48
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Before entering the study, participants had to be treated with MTX for at least 12 weeks and at a stable dose for at least 8 weeks before the screening visit (10-25 mg per week [mg/week] of oral or parenteral MTX).
During the study, treatment with MTX had to be stable during the first month and then could be continued or modified, at the investigator's discretion.
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Baseline and Weeks 24 and 48
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HAQ-DI During the Double-Blind Treatment Period
Временное ограничение: Screening and Week 4
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.
Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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Screening and Week 4
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HAQ-DI During the Open Treatment Period
Временное ограничение: Baseline and Weeks 12, 24, 36, and 48
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.
Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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Baseline and Weeks 12, 24, 36, and 48
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Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period
Временное ограничение: Day 0, Week 1, and Week 4
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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 patient's fatigue.
For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response).
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 = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Day 0, Week 1, and Week 4
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Percent Change From Baseline in FACIT-F During the Double-Blind Treatment Period
Временное ограничение: Week 1 and Week 4
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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 patient's fatigue.
For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response).
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 = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Week 1 and Week 4
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FACIT-F During the Open Treatment Period
Временное ограничение: Baseline, Weeks 12, 24, 36, and 48
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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 patient's fatigue.
For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response).
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 = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Baseline, Weeks 12, 24, 36, and 48
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Hemoglobin Concentration During the Double-Blind Treatment Period
Временное ограничение: Baseline and Weeks 1 and 4
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Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as grams per deciliter (g/dL).
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Baseline and Weeks 1 and 4
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Hemoglobin Concentration During the Open Treatment Period
Временное ограничение: Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
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Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as g/dL.
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Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
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Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period
Временное ограничение: Baseline and Weeks 1 and 4
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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 = value at Day 0 if available, value at screening otherwise.
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Baseline and Weeks 1 and 4
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Percent Change From Baseline in TJC Based on 28-Joint Count During the Double-Blind Treatment Period
Временное ограничение: Weeks 1 and 4
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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.
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Weeks 1 and 4
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TJC Based on 28-Joint Count During the Open Treatment Period
Временное ограничение: Baseline and Weeks 12, 24, 36, and 48
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Twenty-eight joints were assessed for tenderness and joints were classified as tender (1)/not tender (0), giving a total possible tender joint count score of 0 to 28.
Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.
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Baseline and Weeks 12, 24, 36, and 48
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TJC Based on 40-Joint Count During the Double-Blind Treatment Period
Временное ограничение: Baseline and Weeks 1 and 4
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Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40.
Baseline = value at Day 0 if available, value at screening otherwise.
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Baseline and Weeks 1 and 4
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Percent Change From Baseline in TJC Based on 40-Joint Count During the Double-Blind Treatment Period
Временное ограничение: Weeks 1 and 4
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Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40.
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Weeks 1 and 4
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TJC Based on 40-Joint Count During the Open Treatment Period
Временное ограничение: Baseline and Weeks 12, 24, 36, and 48
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Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40.
Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.
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Baseline and Weeks 12, 24, 36, and 48
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Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period
Временное ограничение: Baseline and Weeks 1 and 4
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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 = value at Day 0 if available, value at screening otherwise.
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Baseline and Weeks 1 and 4
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Percent Change From Baseline in SJC Based on 28-Joint Count During the Double-Blind Treatment Period
Временное ограничение: Weeks 1 and 4
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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.
|
Weeks 1 and 4
|
|
Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period
Временное ограничение: Baseline and Weeks 12, 24, 36, and 48
|
Twenty-eight joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints) .
Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28.
Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.
|
Baseline and Weeks 12, 24, 36, and 48
|
|
SJC Based on 40-Joint Count During the Double-Blind Treatment Period
Временное ограничение: Baseline and Weeks 1 and 4
|
Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40.
Baseline = value at Day 0 if available, value at screening otherwise.
|
Baseline and Weeks 1 and 4
|
|
Percent Change From Baseline in SJC Based on 40-Joint Count During the Double-Blind Treatment Period
Временное ограничение: Weeks 1 and 4
|
Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40.
|
Weeks 1 and 4
|
|
SJC Based on 40-Joint Count During the Open Treatment Period
Временное ограничение: Baseline and Weeks 12, 24, 36, and 48
|
Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as swollen (1)/not swollen (0) for a total possible score of 0 to 40.
Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.
|
Baseline and Weeks 12, 24, 36, and 48
|
|
Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period
Временное ограничение: Baseline and Weeks 1 and 4
|
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
|
Baseline and Weeks 1 and 4
|
|
DAS28 During the Open Treatment Period
Временное ограничение: Baseline and Weeks 12, 24, 36, and 48
|
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
|
Baseline and Weeks 12, 24, 36, and 48
|
|
Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period
Временное ограничение: Baseline and Weeks 1 and 4
|
DAS40 calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
|
Baseline and Weeks 1 and 4
|
|
DAS40 During the Open Treatment Period
Временное ограничение: Baseline and Weeks 12, 24, 36, and 48
|
DAS40 was calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate, and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS40 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
|
Baseline and Weeks 12, 24, 36, and 48
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
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 июня 2009 г.
Первичное завершение (Действительный)
1 октября 2011 г.
Завершение исследования (Действительный)
1 октября 2011 г.
Даты регистрации исследования
Первый отправленный
18 августа 2009 г.
Впервые представлено, что соответствует критериям контроля качества
14 сентября 2009 г.
Первый опубликованный (Оценивать)
15 сентября 2009 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
22 сентября 2014 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
15 сентября 2014 г.
Последняя проверка
1 сентября 2014 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ML22017
- 2008-008309-23
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. .
Клинические исследования tocilizumab [RoActemra/Actemra]
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Fresenius Kabi SwissBioSim GmbHЗавершенныйЗдоровыйНовая Зеландия
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Hoffmann-La RocheЗавершенный
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University Hospital for Infectious Diseases, CroatiaНеизвестныйCOVID-19 | Тяжелая пневмонияХорватия
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Bio-Thera SolutionsЗавершенный
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Fresenius Kabi SwissBioSim GmbHЗавершенныйРевматоидный артритВенгрия, Сербия, Грузия, Российская Федерация, Словакия, Чехия, Болгария, Молдова, Республика, Польша
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CelltrionРекрутингЗдоровые субъектыКорея, Республика
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Bio-Thera SolutionsАктивный, не рекрутирующий
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Bio-Thera SolutionsЗавершенный
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CelltrionЕще не набирают
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Medical University of ViennaЗавершенный