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

12. Januar 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

1225

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Adult patients with rheumatoid arthritis

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Kohorte

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2012

Primärer Abschluss (Tatsächlich)

1. Februar 2015

Studienabschluss (Tatsächlich)

1. Februar 2015

Studienanmeldedaten

Zuerst eingereicht

28. Februar 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Februar 2012

Zuerst gepostet (Schätzen)

5. März 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

10. Februar 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Januar 2016

Zuletzt verifiziert

1. Januar 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MA27950

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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