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 listopada 2016 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
304
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Calabria
-
Reggio Calabria, Calabria, Włochy, 89133
-
-
Campania
-
Napoli, Campania, Włochy, 80131
-
Telese Terme, Campania, Włochy, 82037
-
-
Emilia-Romagna
-
Bologna, Emilia-Romagna, Włochy, 40138
-
-
Lazio
-
Roma, Lazio, Włochy, 00133
-
Roma, Lazio, Włochy, 00152
-
Roma, Lazio, Włochy, 00161
-
Roma, Lazio, Włochy, 00189
-
-
Lombardia
-
Legnano, Lombardia, Włochy, 20025
-
Milano, Lombardia, Włochy, 20157
-
Milano, Lombardia, Włochy, 20162
-
Monza, Lombardia, Włochy, 20052
-
Pavia, Lombardia, Włochy, 27100
-
-
Marche
-
Ancona, Marche, Włochy, 60020
-
Jesi, Marche, Włochy, 60035
-
-
Piemonte
-
Torino, Piemonte, Włochy, 10126
-
Torino, Piemonte, Włochy, 10128
-
-
Puglia
-
Bari, Puglia, Włochy, 70124
-
Martina Franca, Puglia, Włochy, 74015
-
-
Sardegna
-
Sassari, Sardegna, Włochy, 07100
-
-
Toscana
-
Firenze, Toscana, Włochy, 50139
-
Pisa, Toscana, Włochy, 56100
-
Prato, Toscana, Włochy, 59100
-
Siena, Toscana, Włochy, 53100
-
-
Umbria
-
Perugia, Umbria, Włochy, 06122
-
-
Veneto
-
Cona (Ferrara), Veneto, Włochy, 44124
-
Padova, Veneto, Włochy, 35128
-
Verona, Veneto, Włochy, 37126
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka prawdopodobieństwa
Badana populacja
Patients with rheumatoid arthritis who have received at least one cycle of therapy with a biologic drug in monotherapy or in combination with DMARDs
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kohorta
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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.
|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
The duration of disease is defined as the total time from the diagnosis of rheumatoid arthritis (RA) until the study entry.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
Comorbidity is the presence of previous or concomitant diseases.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
Participants who received at least one previous treatment with biologics in monotherapy and no previous monotherapy with biologics are reported.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
Participants who had prevalence with at least one previous switch, swaps, and switch/swap to other therapy are reported.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy
Ramy czasowe: Up to 18 months
|
The probabilities of participant to retain on therapy at various time points are reported.
|
Up to 18 months
|
|
Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18
Ramy czasowe: At month 18
|
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.
|
At month 18
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Phase I: Median Disease Duration in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
The duration of disease is defined as the total time from the diagnosis of RA until the study entry.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
Comorbidity is the presence of previous or concomitant diseases.
Percentage of participants with comorbidity is reported.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
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
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With at Least One Previous Treatment With Biologics Drug as a Monotherapy in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
Number of participants who received at least one previous treatment with a biologic drug as a monotherapy in both groups is reported.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Percentage of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
Participants who had prevalence with at least one previous switch, swaps or switch/swap to other therapy either monotherapy or combination therapy are reported.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Median DAS28 at Study Entry in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With CDAI Scores at Study Entry in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Number of Participants With SDAI Scores at Study Entry in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Mean Tender Joints and Swollen Joints as Disease Activity at Study Entry in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
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.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Percentage of Participants Treated With Corticosteroids at Study Entry in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
The percentage of participants treated with corticosteroids at enrollment is reported.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Mean Dose of Corticosteroids At Study Entry in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
Mean dose of corticosteroids at study entry (Baseline) is reported.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Mean Duration of Previous Treatment With a Biologic Drug in Monotherapy and Combination Therapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
Mean duration of previous treatment with a biologic drug in monotherapy are reported.
|
At Baseline (Day of informed consent form signed)
|
|
Phase I: Mean Duration of Treatment With A Biologic Drug in Combination With DMARDs Before Monotherapy
Ramy czasowe: At Baseline (Day of informed consent form signed)
|
Mean duration of treatment with a biologic drug in combination with DMARDs before monotherapy is reported in days.
|
At Baseline (Day of informed consent form signed)
|
|
Phase II: Percentage of Participants Maintaining Delta DAS 28 CRP of >= 0.6 at Months 3, 6, 12, and 18
Ramy czasowe: At Months 3, 6, 12, and 18
|
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.
|
At Months 3, 6, 12, and 18
|
|
Phase II: Percentage of Participants Maintaining Delta DAS28 ESR >= 0.6 at Months 3, 6, 12, and 18
Ramy czasowe: At Months 3, 6, 12, and 18
|
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.
|
At Months 3, 6, 12, and 18
|
|
Phase II: Percentage of Participants Achieving DAS28 CRP Remission (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18
Ramy czasowe: At Months 3, 6, 12, and 18
|
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.
|
At Months 3, 6, 12, and 18
|
|
Phase II: Percentage of Participants Achieving DAS 28 ESR (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18
Ramy czasowe: At Months 3, 6, 12, and 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.
The DAS28 ESR < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.
|
At Months 3, 6, 12, and 18
|
|
Phase II: Percentage of Participants Achieving CDAI Remission (< 2.8) at Months 3, 6, 12, and 18
Ramy czasowe: At Months 3, 6, 12, and 18
|
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.
|
At Months 3, 6, 12, and 18
|
|
Phase II: Percentage of Participant Achieving SDAI Remission (< 3.3) at Months 3, 6, 12, and 18
Ramy czasowe: At Months 3, 6, 12, and 18
|
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.
|
At Months 3, 6, 12, and 18
|
|
Phase II: Mean Change From Baseline in TJC And SJC at Months 3, 6, 12, and 18
Ramy czasowe: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
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.
|
From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
|
Phase II: Mean Change From Baseline in Dose of Corticosteroids at Months 3, 6, 12, and 18
Ramy czasowe: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
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.
|
From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
|
Phase II: Percentage of Participants With Delta HAQ >= 0.21 at Months 3, 6, 12, and 18
Ramy czasowe: At Months 3, 6, 12, and 18
|
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.
|
At Months 3, 6, 12, and 18
|
|
Phase II: Mean VAS Fatigue Score Overtime
Ramy czasowe: At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18
|
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.
|
At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18
|
|
Phase II: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Adverse Events of Special Interest, and Tubercular Events
Ramy czasowe: Up to 18 months
|
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.
|
Up to 18 months
|
|
Phase II: Number of Participants With Retention in Therapy Without Interruption Due to Side Effects
Ramy czasowe: Up to 18 months
|
Number of participants who retained in therapy without interruption due to side effects is reported.
|
Up to 18 months
|
|
Phase II: Number of Side Effects That Had Not Induced Discontinuation of Treatment
Ramy czasowe: Up to 18 months
|
Number of side effects (AEs) that had not induced discontinuation of treatment is reported.
The AEs were captured only for Phase II.
|
Up to 18 months
|
|
Phase II: Number of Side Effects That Induced Transient Interruption of Treatment
Ramy czasowe: Up to 18 months
|
Number of side effects (AEs) that induced transient interruption of treatment is reported.
The AEs were captured only for Phase II.
|
Up to 18 months
|
|
Phase II: Mean Change From Baseline in Hemoglobin Levels Over Time
Ramy czasowe: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
The mean change in hemoglobin concentration was calculated by subtracting the baseline hemoglobin concentration from the monthly hemoglobin concentration is reported.
|
From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
|
Phase II: Mean Change From Baseline in Hematocrit, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes Over Time
Ramy czasowe: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
Mean Change from Baseline in hematocrit, neutrophils, eosinophils, basophils, lymphocytes, monocytes are reported.
|
From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
|
Phase II: Mean Change From Baseline in Red Blood Cells, White Blood Cells, and Platelets Over Time
Ramy czasowe: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
Mean change from baseline in red blood cells (RBC), white blood cells (WBC) and platelets are reported.
|
From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
|
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
Ramy czasowe: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
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.
|
From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
|
Phase II: Mean Change From Baseline in Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyl Transpeptidase, and Alkaline Phosphatase Levels Over Time
Ramy czasowe: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
Mean change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase levels are reported.
|
From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
|
Phase II: Mean Change From Baseline in Serum Electrophoresis Parameters Over Time
Ramy czasowe: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
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.
|
From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 maja 2013
Zakończenie podstawowe (Rzeczywisty)
1 października 2014
Ukończenie studiów (Rzeczywisty)
1 października 2014
Daty rejestracji na studia
Pierwszy przesłany
12 lutego 2013
Pierwszy przesłany, który spełnia kryteria kontroli jakości
12 lutego 2013
Pierwszy wysłany (Oszacować)
13 lutego 2013
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
10 stycznia 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 listopada 2016
Ostatnia weryfikacja
1 listopada 2016
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ML28552
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .