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An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

12 stycznia 2016 zaktualizowane przez: Hoffmann-La Roche

A Global Comparative Observational Study In Rheumatoid Arthritis (RA) Patients Who Are Treated With A TNF Inhibitor Or Tocilizumab As The First Biologic Therapy

This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.

Przegląd badań

Status

Zakończony

Warunki

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

1225

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
      • Catamarca Capital, Argentyna, 4700
      • Mendoza, Argentyna, 5500
      • Mendoza, Argentyna, 5501
      • Rosario, Argentyna, S2000PBJ
  • Belgia
      • AYE, Belgia, 6900
      • Aalst, Belgia, 9300
      • Assebroek, Belgia, 8310
      • Bruxelles, Belgia, 1050
      • Bruxelles, Belgia, 1000
      • Edegem, Belgia, 2650
      • Genk, Belgia, 3600
      • Gent, Belgia, 9000
      • Godinne, Belgia, 5530
      • Heusy, Belgia, 4802
      • Liège, Belgia, 4000
      • Oostende, Belgia, 8400
      • Verviers, Belgia, 4800
      • Westmalle, Belgia, 2390
  • Ekwador
      • Cuenca, Ekwador
      • Esmeraldas, Ekwador, EC080150
      • Guayaquil, Ekwador, EC090114
      • Portoviejo, Ekwador
      • Quito, Ekwador, 005932
      • Quito, Ekwador, EC170135
      • Quito, Ekwador, EC170412
  • Grecja
      • Athens, Grecja, 11527
      • Athens, Grecja, 155 62
      • Patra, Grecja, 26335
      • Thessaloniki, Grecja, 56429
      • Thessaloniki, Grecja, 544 65
  • Gwatemala
      • Ciudad de Guatemala, Gwatemala
  • Hiszpania
      • Madrid, Hiszpania, 28006
      • Madrid, Hiszpania, 28905
      • Madrid, Hiszpania, 28007
    • Madrid
      • Fuenlabrada, Madrid, Hiszpania, 28942
      • San Sebastian de los Reyes, Madrid, Hiszpania, 28702
  • Kolumbia
      • Barranquilla, Kolumbia
      • Bogota, Kolumbia
      • Bucaramanga, Kolumbia
      • Medellin, Kolumbia
  • Meksyk
      • Guadalajara, Meksyk, 44650
      • Guadalajara, Meksyk, 44600
      • Guadalajara, Meksyk, 45040
      • Mexicali, Meksyk, 21100
      • Mexico Ctiy, Meksyk, 07760
  • Niemcy
      • Aachen, Niemcy, 52064
      • Bad Aibling, Niemcy, 83043
      • Bad Neuenahr-Ahrweiler, Niemcy, 53474
      • Bayreuth, Niemcy, 95445
      • Berlin, Niemcy, 13055
      • Dresden, Niemcy, 01109
      • Erfurt, Niemcy, 99096
      • Erlangen, Niemcy, 91056
      • Fulda, Niemcy, 36043
      • Hamburg, Niemcy, 22767
      • Hamburg, Niemcy, 22147
      • Heidelberg, Niemcy, 69121
      • Herne, Niemcy, 44652
      • Köln, Niemcy, 50937
      • Ludwigsfelde, Niemcy, 14974
      • München, Niemcy, 81541
      • München, Niemcy, 80639
      • Passau, Niemcy, 94032
      • Rostock, Niemcy, 18059
      • Stuttgart, Niemcy, 70178
      • Traunstein, Niemcy, 83278
      • Wuppertal, Niemcy, 42105
  • Panama
      • Panama City, Panama, 32400
  • Portugalia
      • Almada, Portugalia, 2801-951
      • Amadora, Portugalia, 2720-276
      • Lisboa, Portugalia, 1649-035
      • Lisboa, Portugalia, 1069-166
      • Porto, Portugalia, 4200-319
      • Porto, Portugalia, 4099-001
      • Vila Nova de Gaia, Portugalia, 4400-129
  • Szwajcaria
      • Aarau, Szwajcaria, 5000
      • Basel, Szwajcaria, 4031
      • Chur, Szwajcaria, 7000
      • St. Gallen, Szwajcaria, 9007
  • Ukraina
      • Donetsk, Ukraina, 83045
      • Kharkiv, Ukraina, 61052
      • Kmelnytskyy, Ukraina, 29000
      • Kyiv, Ukraina, 02125
      • Kyiv, Ukraina, 03151
      • Kyiv, Ukraina, 1023
      • Odesa, Ukraina, 65026
      • Uzhgorod, Ukraina, 88000
      • Zaporizhzhya, Ukraina, 69600
  • Urugwaj
      • Montevideo, Urugwaj, 11000
      • Montevideo, Urugwaj, 11800
  • Włochy
    • Abruzzo
      • Coppito, Abruzzo, Włochy, 67100
      • Pescara, Abruzzo, Włochy, 65100
    • Calabria
      • Reggio Calabria, Calabria, Włochy, 89133
    • Campania
      • Avellino, Campania, Włochy, 83100
      • Napoli, Campania, Włochy, 80131
      • Napoli, Campania, Włochy, 80144
      • Salerno, Campania, Włochy, 84131
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Włochy, 33100
    • Lazio
      • Roma, Lazio, Włochy, 00133
      • Roma, Lazio, Włochy, 00189
    • Liguria
      • Arenzano, Liguria, Włochy, 16011
    • Lombardia
      • Brescia, Lombardia, Włochy, 25123
      • Legnano, Lombardia, Włochy, 20025
      • Milano, Lombardia, Włochy, 20157
      • Milano, Lombardia, Włochy, 20162
    • Marche
      • Jesi Ancona, Marche, Włochy, 60035
    • Molise
      • Agnone, Molise, Włochy, 86081
    • Piemonte
      • Torino, Piemonte, Włochy, 10126
      • Torino, Piemonte, Włochy, 10128
    • Puglia
      • Brindisi, Puglia, Włochy, 72100
      • Martina Franca, Puglia, Włochy, 74015
      • San Cesario Di Lecce, Puglia, Włochy, 73016
    • Sicilia
      • Catania, Sicilia, Włochy, 95124
    • Toscana
      • Prato, Toscana, Włochy, 59100
    • Umbria
      • Perugia, Umbria, Włochy, 06122
  • Zjednoczone Królestwo
      • Barnsley, Zjednoczone Królestwo, S75 2EP
      • Basildon, Zjednoczone Królestwo, SS16 5NL
      • Basingstoke, Zjednoczone Królestwo, RG24 9NA
      • Brighton, Zjednoczone Królestwo, BN2 5BE
      • Cannock, Zjednoczone Królestwo, WS11 5XY
      • Cardiff, Zjednoczone Królestwo, CF14 4XW
      • Chertsey, Zjednoczone Królestwo, KT16 0PZ
      • Crawley, Zjednoczone Królestwo, RH11 7DH
      • Darlington, Zjednoczone Królestwo, DL3 6HX
      • Enfield, Zjednoczone Królestwo, EN2 8JL
      • Grimsby, Zjednoczone Królestwo, DN33 2BA
      • Guildford, Zjednoczone Królestwo, GU2 7XX
      • Ipswich, Zjednoczone Królestwo, IP4 5PD
      • Kettering, Zjednoczone Królestwo, NN16 8UZ
      • Lancaster, Zjednoczone Królestwo, LA1 4RP
      • Leeds, Zjednoczone Królestwo, LS7 4SA
      • Llandudno, Zjednoczone Królestwo, LL30 1LB
      • London, Zjednoczone Królestwo, W6 8RF
      • London, Zjednoczone Królestwo, SW17 0QT
      • London, Zjednoczone Królestwo, SE18 4QH
      • Luton, Zjednoczone Królestwo, LU4 0DZ
      • Maidstone, Zjednoczone Królestwo, ME16 9QQ
      • Margate, Zjednoczone Królestwo, CT9 4AN
      • North Shields, Zjednoczone Królestwo, NE29 8NH
      • Oswestry, Zjednoczone Królestwo, SY10 7AG
      • Plymouth, Zjednoczone Królestwo, PL6 8DH
      • Portsmouth, Zjednoczone Królestwo, PO6 3LY
      • Reading, Zjednoczone Królestwo, RG1 5AN
      • Rhyl, Zjednoczone Królestwo, LL18 5UJ
      • Romford, Zjednoczone Królestwo, RM7 0AG
      • Sheffield, Zjednoczone Królestwo, S10 2JF
      • Stockport, Zjednoczone Królestwo, SK2 7JE
      • Sunderland, Zjednoczone Królestwo, SR4 7TP
      • Swindon, Zjednoczone Królestwo, SN3 6BB
      • Torquay, Zjednoczone Królestwo, TQ2 7AA
      • Warrington, Zjednoczone Królestwo, WA5 1QG
      • Wirral, Zjednoczone Królestwo, CH49 5PE
      • Wolverhampton, Zjednoczone Królestwo, WV10 0QP
      • Wrightington, Zjednoczone Królestwo, WN6 9EP

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

Adult patients with rheumatoid arthritis

Opis

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of rheumatoid arthritis
  • Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
  • Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed

Exclusion Criteria:

  • Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
  • Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
  • Patients whose first biologic is rituximab, abatacept or anakinra.
  • Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit

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

Kohorty i interwencje

Grupa / Kohorta
Kohorta

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
Ramy czasowe: Baseline and Week 24
Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker [erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (</=) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Week 24

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
Ramy czasowe: Baseline and Week 52
Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Week 52
Mean Change From Baseline in Erythrocyte Sedimentation Rate
Ramy czasowe: Baseline, Week 24, Week 52
Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.
Baseline, Week 24, Week 52
Mean Change From Baseline in C-reactive Protein
Ramy czasowe: Baseline, Week 24, Week 52
Blood samples were collected for C-reactive protein (CRP). CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA.
Baseline, Week 24, Week 52
Mean Change From Baseline in Swollen Joint Count
Ramy czasowe: Baseline, Week 24, Week 52
A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. 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, Week 24, Week 52
Mean Change From Baseline in Tender Joint Count
Ramy czasowe: Baseline, Week 24, Week 52
A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. 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, Week 24, Week 52
Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score
Ramy czasowe: Baseline, Week 24, Week 52
Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP. SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.
Baseline, Week 24, Week 52
Mean Change From Baseline in Physician Global Assessment Score
Ramy czasowe: Baseline, Week 24, Week 52
The Physician's Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). Change from baseline = scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline, Week 24, Week 52
Loss of Efficacy or Development of Intolerance to Biologic Therapy
Ramy czasowe: Up to Week 52
Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.
Up to Week 52
Proportion of Participants Who Terminated Biologic Treatment
Ramy czasowe: Up to Week 52
The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.
Up to Week 52
Reasons for Treatment Discontinuation
Ramy czasowe: Up to Week 52
The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.
Up to Week 52
Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period
Ramy czasowe: Up to end of treatment
The total number of participants who discontinued biologic therapy at the end of each study period (Week 0 - 24, Week 24 - 52, Week 52 - 57 and Week 57 - end of treatment) is presented. Participants who did not have a biologic therapy discontinuation or discontinued before having one, were considered as 'censored' at the date study termination.
Up to end of treatment
Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy
Ramy czasowe: Up to Week 52
An infusion reaction was defined as an adverse event (AE) occurring during and within 24 hours after the infusion, which may include hypersensitivity reactions or anaphylactic reactions. Injection site reactions were included in the summaries for infusion reactions.
Up to Week 52
Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events
Ramy czasowe: Up to Week 52
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Up to Week 52
Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study
Ramy czasowe: Up to Week 52
Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Based on seriousness criteria, they were categorized as serious and non-serious adverse events of special interest.
Up to Week 52
Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score
Ramy czasowe: Baseline, Week 24, Week 52
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
Baseline, Week 24, Week 52
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score
Ramy czasowe: Baseline, Week 24, Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (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 participant's fatigue. 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, Week 24, Week 52
Mean Change From Baseline in Visual Analogue Scale Pain Score
Ramy czasowe: Baseline, Week 24, Week 52
VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from baseline =scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline, Week 24, Week 52
Shift From Baseline in Morning Stiffness
Ramy czasowe: Baseline, Week 24, Week 52
Shift tables presenting the number of participants in each bivariate category Week (W) 0 versus Week 24 and Week 52, with regards to morning stiffness at the different time points, was presented for each treatment arm. For participants who experienced joint stiffness while waking up in the morning, duration of morning stiffness was categorized as follows: Less than 30 minutes (min), Between 30 and 60 minutes, Between 60 and 120 minutes, Between 120 to 240 minutes, More than 240 minutes and the whole day. Baseline = BL
Baseline, Week 24, Week 52
Change From Baseline in Patient Global Assessment of Disease Activity
Ramy czasowe: Baseline, Week 24, Week 52
The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Baseline, Week 24, Week 52

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hoffmann-La Roche

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

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 lutego 2012

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2015

Ukończenie studiów (Rzeczywisty)

1 lutego 2015

Daty rejestracji na studia

Pierwszy przesłany

28 lutego 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 lutego 2012

Pierwszy wysłany (Oszacować)

5 marca 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

10 lutego 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 stycznia 2016

Ostatnia weryfikacja

1 stycznia 2016

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • MA27950

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 .

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