ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis
14 de novembro de 2016 atualizado por: Hoffmann-La Roche
A Multi-Center Observational Study on the Use of Biologic Drugs as Monotherapy or Combination With DMARDs in Patients With Rheumatoid Arthritis in Italian Clinical Practice (ARMONIA)
This is a multicenter observational study in patients with rheumatoid arthritis in routine clinical practice in Italy.
In the retrospective Part 1 of the study, clinical and demographic factors associated with the use of a biologic drug in monotherapy as compared to therapy in combination with Disease-modifying anti-rheumatic drugs (DMARDs) will be evaluated.
In the retrospective/prospective Part 2 of the study, efficacy and safety of the use of RoActemra/Actemra (tocilizumab) in monotherapy will be evaluated.
Patients will be followed for up to18 months.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
304
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Calabria
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Reggio Calabria, Calabria, Itália, 89133
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Campania
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Napoli, Campania, Itália, 80131
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Telese Terme, Campania, Itália, 82037
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Emilia-Romagna
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Bologna, Emilia-Romagna, Itália, 40138
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Lazio
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Roma, Lazio, Itália, 00133
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Roma, Lazio, Itália, 00152
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Roma, Lazio, Itália, 00161
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Roma, Lazio, Itália, 00189
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Lombardia
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Legnano, Lombardia, Itália, 20025
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Milano, Lombardia, Itália, 20157
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Milano, Lombardia, Itália, 20162
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Monza, Lombardia, Itália, 20052
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Pavia, Lombardia, Itália, 27100
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Marche
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Ancona, Marche, Itália, 60020
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Jesi, Marche, Itália, 60035
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Piemonte
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Torino, Piemonte, Itália, 10126
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Torino, Piemonte, Itália, 10128
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Puglia
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Bari, Puglia, Itália, 70124
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Martina Franca, Puglia, Itália, 74015
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Sardegna
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Sassari, Sardegna, Itália, 07100
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Toscana
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Firenze, Toscana, Itália, 50139
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Pisa, Toscana, Itália, 56100
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Prato, Toscana, Itália, 59100
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Siena, Toscana, Itália, 53100
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Umbria
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Perugia, Umbria, Itália, 06122
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Veneto
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Cona (Ferrara), Veneto, Itália, 44124
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Padova, Veneto, Itália, 35128
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Verona, Veneto, Itália, 37126
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Patients with rheumatoid arthritis who have received at least one cycle of therapy with a biologic drug in monotherapy or in combination with DMARDs
Descrição
Inclusion Criteria:
Part 1:
- Adult patients, >/= 18 years of age
- Diagnosis of rheumatoid arthritis according to American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria
- Patients who received at least one cycle of biologic therapy, either in monotherapy or in combination, in the 12 months preceding the opening of the first site
Part 2:
- Patients on monotherapy with RoActemra/Actemra already enrolled in Part 1 of the study
Exclusion Criteria:
- Patients simultaneously participating in other studies with RoActemra/Actemra at the time of signing informed consent
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
Coortes e Intervenções
Grupo / Coorte |
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Monotherapy
Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry will be observed for Phase I. Participants who were enrolled in Phase I and received tocilizumab (TCZ) as a monotherapy will be observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
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Combination Therapy
Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry will be observed for Phase I.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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Demographic characteristics were analyzed in participants at Baseline, where Baseline is considered as the study entry visit (day of informed consent form signed). Demographic characteristics which were taken into account included age in years, race, height in centimeters (cm), weight in Kilograms (Kg), and Body Mass Index (BMI) in Kg/cm^2.
Participants with age =<, > 59 years, height =<, > 163 cm, weight =<, > 65.85 Kg and BMI =<, > 24.98 Kg/cm^2 are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The duration of disease is defined as the total time from the diagnosis of rheumatoid arthritis (RA) until the study entry.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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Comorbidity is the presence of previous or concomitant diseases.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The autoantibody included seropositive or seronegative participants for rheumatoid factor (RF) and/or anti-cyclic citrullinated protein antibodies (Anti-CCP).
RF value higher than 20 Units (U)/milliliter (mL) is considered seropositive and anti-CCP antibodies value higher than 10 U/mL is considered positive.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The Health Assessment Questionnaire- Disability Index (HAQ-DI) is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis.
It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all.
The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity.
Participants assessed their ability to do each task over the past seven days.
Participants with scores =< 0.8625 and > 0.8625 are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The disease activity included Disease Activity Score 28 (DAS28).
The DAS28 is a combined index for measuring disease activity in RA.
The index includes swollen joint counts (SJC) and tender joint counts (TJC), acute phase response, and general health status.
The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity; where higher scores represents higher disease activity.
The DAS =< 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
Participants with DAS28 score =< 2.6 and > 2.6 are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The disease activity included biological markers of inflammation: C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).
A reduction in CRP and ESR values indicates improvement.
Participants with CRP values =< 0.28 and >2.8 milligram/deciliter (mg/dL); and ESR values =< 11 and >11 millimeters/hour (mm/hr) are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The disease activity included Clinical Disease Activity Index (CDAI) which is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and patient's global assessment (PtGA) and physician's global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS), where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity.
The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity.
The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity.
Participants with CDAI score =< 7.75 and > 7.75 are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The disease activity included Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP.
SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity.
The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.
Participants with SDAI score =< 8.17 and > 8.17 are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The duration of combination therapy before monotherapy are reported.
The duration was estimated by calculating total duration from starting the combination therapy till the participant switched to monotherapy.
Participants who started the combination therapy and later switched to monotherapy =< 337 days, > 337 days, =< 336 days, > 336 days are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy
Prazo: At Baseline (Day of informed consent form signed)
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The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs and the second treatment line as the subsequent use of a different biologic drug.
Participants who adopted monotherapy as =< 2 and > 2 therapy lines are reported.
According to the study protocol objectives, this analysis was performed only for Monotherapy arm.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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Participants who received at least one previous treatment with biologics in monotherapy and no previous monotherapy with biologics are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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Participants who had prevalence with at least one previous switch, swaps, and switch/swap to other therapy are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy
Prazo: At Baseline (Day of informed consent form signed)
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Reasons leading to the use of biologic in monotherapy includes DMARDs intolerance, insufficient therapeutic effect, intolerance to biologic drug, low participant's compliance, concomitant pathologies, pregnancy desire, remission from combination therapy, remission from monotherapy, others and unknown.
Participants with reason leading to the use of biologic in monotherapy are presented.
According to the study protocol objectives, this analysis was performed only for Monotherapy arm.
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At Baseline (Day of informed consent form signed)
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Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy
Prazo: Up to 18 months
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The probabilities of participant to retain on therapy at various time points are reported.
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Up to 18 months
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Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18
Prazo: At month 18
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Participants who retained the therapy were analyzed for disease activity (DAS28 ESR) at Month 18.
The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR.
It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA.
The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.
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At month 18
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Phase I: Median Disease Duration in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The duration of disease is defined as the total time from the diagnosis of RA until the study entry.
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At Baseline (Day of informed consent form signed)
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Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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Comorbidity is the presence of previous or concomitant diseases.
Percentage of participants with comorbidity is reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The HAQ-DI is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis.
It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all.
The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity.
Participants assessed their ability to do each task over the past seven days.
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At Baseline (Day of informed consent form signed)
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Phase I: Percentage of Participants Who Started Treatment With a Biologic Drug in Monotherapy and Percentage of Participants Who Stopped a DMARDs While Taking a Biologic Drug in Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The table below shows percentage participants who started treatment with a biologic drug in monotherapy compared with percentage of participants who stopped DMARDs while taking a biologic drug in combination.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines
Prazo: At Baseline (Day of informed consent form signed)
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The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs, the second treatment line as the subsequent use of a different biologic drug and so on for the third, fourth, fifth and sixth treatment line.
According to the study protocol objectives, this analysis was performed only for Monotherapy arm.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With at Least One Previous Treatment With Biologics Drug as a Monotherapy in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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Number of participants who received at least one previous treatment with a biologic drug as a monotherapy in both groups is reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Percentage of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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Participants who had prevalence with at least one previous switch, swaps or switch/swap to other therapy either monotherapy or combination therapy are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Median DAS28 at Study Entry in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The DAS28 is a combined index for measuring disease activity in RA.
The index includes SJC and TJC, acute phase response, and general health status.
The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity) where higher scores represents higher disease.
The DAS28 <2.6 indicates disease remission, >=2.6 and <3.2 indicates Low disease activity, >=3.2 and <=5.1 indicates Moderate disease activity and >5.1 indicates High disease activity.
Median score for DAS28 at the study entry (Baseline) is reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With CDAI Scores at Study Entry in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity.
The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity.
The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity.
Number of participants with CDAI scores for both the groups at study entry (baseline) are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Number of Participants With SDAI Scores at Study Entry in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm) VAS; 0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL).
SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity.
The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.
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At Baseline (Day of informed consent form signed)
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Phase I: Mean Tender Joints and Swollen Joints as Disease Activity at Study Entry in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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Mean of tender and swollen joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion.
The number of tender and swollen joints was recorded on the joint assessment as no tenderness = 0 and tenderness = 1.
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At Baseline (Day of informed consent form signed)
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Phase I: Percentage of Participants Treated With Corticosteroids at Study Entry in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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The percentage of participants treated with corticosteroids at enrollment is reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Mean Dose of Corticosteroids At Study Entry in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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Mean dose of corticosteroids at study entry (Baseline) is reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Mean Duration of Previous Treatment With a Biologic Drug in Monotherapy and Combination Therapy
Prazo: At Baseline (Day of informed consent form signed)
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Mean duration of previous treatment with a biologic drug in monotherapy are reported.
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At Baseline (Day of informed consent form signed)
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Phase I: Mean Duration of Treatment With A Biologic Drug in Combination With DMARDs Before Monotherapy
Prazo: At Baseline (Day of informed consent form signed)
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Mean duration of treatment with a biologic drug in combination with DMARDs before monotherapy is reported in days.
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At Baseline (Day of informed consent form signed)
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Phase II: Percentage of Participants Maintaining Delta DAS 28 CRP of >= 0.6 at Months 3, 6, 12, and 18
Prazo: At Months 3, 6, 12, and 18
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Participants who maintained the change in DAS28 (Delta DAS28) CRP of >=0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported.
The DAS28-CRP is a combined index that measured RA disease activity.
It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL).
It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC 28 + 0.28 square root of SJC 28 + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96.
The DAS28 CRP- scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.
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At Months 3, 6, 12, and 18
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Phase II: Percentage of Participants Maintaining Delta DAS28 ESR >= 0.6 at Months 3, 6, 12, and 18
Prazo: At Months 3, 6, 12, and 18
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Participants who maintained delta DAS28 ESR of >= 0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported.
The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR.
It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA.
The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); where decrease in score indicated improvement of disease.
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At Months 3, 6, 12, and 18
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Phase II: Percentage of Participants Achieving DAS28 CRP Remission (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18
Prazo: At Months 3, 6, 12, and 18
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The DAS28-CRP is a combined index that measured RA disease activity.
It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL).
It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC (28 joints) + 0.28 square root of SJC (28 joints) + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96.
The DAS28 CRP scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.
The DAS28 CRP < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.
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At Months 3, 6, 12, and 18
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Phase II: Percentage of Participants Achieving DAS 28 ESR (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18
Prazo: At Months 3, 6, 12, and 18
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The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR.
It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA.
The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.
The DAS28 ESR < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.
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At Months 3, 6, 12, and 18
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Phase II: Percentage of Participants Achieving CDAI Remission (< 2.8) at Months 3, 6, 12, and 18
Prazo: At Months 3, 6, 12, and 18
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Percentage of participants achieving CDAI remission < 2.8, after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported.
CDAI is the numerical sum of four outcome parameters: TJC, SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity.
The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity.
The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity.
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At Months 3, 6, 12, and 18
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Phase II: Percentage of Participant Achieving SDAI Remission (< 3.3) at Months 3, 6, 12, and 18
Prazo: At Months 3, 6, 12, and 18
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Percentage of participant achieving SDAI remission (< 3.3), after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy is reported.
The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA which (based on 0-10 cm VAS, 0 = no disease activity and 10 = worst disease activity, where higher scores represent higher disease activity), and CRP.
The SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity.
The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.
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At Months 3, 6, 12, and 18
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Phase II: Mean Change From Baseline in TJC And SJC at Months 3, 6, 12, and 18
Prazo: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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The mean change from Baseline (day of the first infusion with tocilizumab as monotherapy) in the TJC And SJC after 3, 6, 12 and 18 months is reported.
The TJC and SJC were determined for 28 joint counts.
The scores ranged from 0 (no disease activity) to 28 (higher/worsen disease activity), where higher scores represents higher disease activity.
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From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Phase II: Mean Change From Baseline in Dose of Corticosteroids at Months 3, 6, 12, and 18
Prazo: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Mean Change From Baseline (day of the first infusion with tocilizumab as monotherapy) in the dose of corticosteroids after 3, 6, 12 and 18 months from Baseline is reported.
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From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Phase II: Percentage of Participants With Delta HAQ >= 0.21 at Months 3, 6, 12, and 18
Prazo: At Months 3, 6, 12, and 18
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Percentage of participants with change in HAQ (Delta HAQ) of >= 0.21 after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported.
The HAQ consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all.
The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity.
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At Months 3, 6, 12, and 18
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Phase II: Mean VAS Fatigue Score Overtime
Prazo: At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18
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The VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity).
Higher score indicate worsening.
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At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18
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Phase II: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Adverse Events of Special Interest, and Tubercular Events
Prazo: Up to 18 months
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An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment.
An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Pre-existing conditions that worsened during the study were reported as AE.
A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.
The AE were captured only for Phase II.
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Up to 18 months
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Phase II: Number of Participants With Retention in Therapy Without Interruption Due to Side Effects
Prazo: Up to 18 months
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Number of participants who retained in therapy without interruption due to side effects is reported.
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Up to 18 months
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Phase II: Number of Side Effects That Had Not Induced Discontinuation of Treatment
Prazo: Up to 18 months
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Number of side effects (AEs) that had not induced discontinuation of treatment is reported.
The AEs were captured only for Phase II.
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Up to 18 months
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Phase II: Number of Side Effects That Induced Transient Interruption of Treatment
Prazo: Up to 18 months
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Number of side effects (AEs) that induced transient interruption of treatment is reported.
The AEs were captured only for Phase II.
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Up to 18 months
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Phase II: Mean Change From Baseline in Hemoglobin Levels Over Time
Prazo: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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The mean change in hemoglobin concentration was calculated by subtracting the baseline hemoglobin concentration from the monthly hemoglobin concentration is reported.
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From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Phase II: Mean Change From Baseline in Hematocrit, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes Over Time
Prazo: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Mean Change from Baseline in hematocrit, neutrophils, eosinophils, basophils, lymphocytes, monocytes are reported.
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From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Phase II: Mean Change From Baseline in Red Blood Cells, White Blood Cells, and Platelets Over Time
Prazo: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Mean change from baseline in red blood cells (RBC), white blood cells (WBC) and platelets are reported.
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From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Phase II: Mean Change From Baseline in Total Cholesterol, Low-density and High-density Lipoprotein Cholesterol, Triglycerides, Total Bilirubin, Direct Bilirubin, Glucose, Creatinine, Blood Urea Nitrogen Levels Over Time
Prazo: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Mean change from baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides (TG), total bilirubin, direct bilirubin, glucose, creatinine, blood urea nitrogen (BUN) levels are reported.
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From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Phase II: Mean Change From Baseline in Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyl Transpeptidase, and Alkaline Phosphatase Levels Over Time
Prazo: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Mean change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase levels are reported.
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From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Phase II: Mean Change From Baseline in Serum Electrophoresis Parameters Over Time
Prazo: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Serum electrophoresis parameters includes albumin, alpha-1 globulin, alpha-2 globulin, beta globulin, gamma globulin was reported.
Mean change from Baseline values are reported at each time points.
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From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2013
Conclusão Primária (Real)
1 de outubro de 2014
Conclusão do estudo (Real)
1 de outubro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
12 de fevereiro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de fevereiro de 2013
Primeira postagem (Estimativa)
13 de fevereiro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
10 de janeiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de novembro de 2016
Última verificação
1 de novembro de 2016
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ML28552
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