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

12. januar 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1225

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Catamarca Capital, Argentina, 4700
      • Mendoza, Argentina, 5500
      • Mendoza, Argentina, 5501
      • Rosario, Argentina, 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
  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Bucaramanga, Colombia
      • Medellin, Colombia
  • Det Forenede Kongerige
      • Barnsley, Det Forenede Kongerige, S75 2EP
      • Basildon, Det Forenede Kongerige, SS16 5NL
      • Basingstoke, Det Forenede Kongerige, RG24 9NA
      • Brighton, Det Forenede Kongerige, BN2 5BE
      • Cannock, Det Forenede Kongerige, WS11 5XY
      • Cardiff, Det Forenede Kongerige, CF14 4XW
      • Chertsey, Det Forenede Kongerige, KT16 0PZ
      • Crawley, Det Forenede Kongerige, RH11 7DH
      • Darlington, Det Forenede Kongerige, DL3 6HX
      • Enfield, Det Forenede Kongerige, EN2 8JL
      • Grimsby, Det Forenede Kongerige, DN33 2BA
      • Guildford, Det Forenede Kongerige, GU2 7XX
      • Ipswich, Det Forenede Kongerige, IP4 5PD
      • Kettering, Det Forenede Kongerige, NN16 8UZ
      • Lancaster, Det Forenede Kongerige, LA1 4RP
      • Leeds, Det Forenede Kongerige, LS7 4SA
      • Llandudno, Det Forenede Kongerige, LL30 1LB
      • London, Det Forenede Kongerige, W6 8RF
      • London, Det Forenede Kongerige, SW17 0QT
      • London, Det Forenede Kongerige, SE18 4QH
      • Luton, Det Forenede Kongerige, LU4 0DZ
      • Maidstone, Det Forenede Kongerige, ME16 9QQ
      • Margate, Det Forenede Kongerige, CT9 4AN
      • North Shields, Det Forenede Kongerige, NE29 8NH
      • Oswestry, Det Forenede Kongerige, SY10 7AG
      • Plymouth, Det Forenede Kongerige, PL6 8DH
      • Portsmouth, Det Forenede Kongerige, PO6 3LY
      • Reading, Det Forenede Kongerige, RG1 5AN
      • Rhyl, Det Forenede Kongerige, LL18 5UJ
      • Romford, Det Forenede Kongerige, RM7 0AG
      • Sheffield, Det Forenede Kongerige, S10 2JF
      • Stockport, Det Forenede Kongerige, SK2 7JE
      • Sunderland, Det Forenede Kongerige, SR4 7TP
      • Swindon, Det Forenede Kongerige, SN3 6BB
      • Torquay, Det Forenede Kongerige, TQ2 7AA
      • Warrington, Det Forenede Kongerige, WA5 1QG
      • Wirral, Det Forenede Kongerige, CH49 5PE
      • Wolverhampton, Det Forenede Kongerige, WV10 0QP
      • Wrightington, Det Forenede Kongerige, WN6 9EP
  • Ecuador
      • Cuenca, Ecuador
      • Esmeraldas, Ecuador, EC080150
      • Guayaquil, Ecuador, EC090114
      • Portoviejo, Ecuador
      • Quito, Ecuador, 005932
      • Quito, Ecuador, EC170135
      • Quito, Ecuador, EC170412
  • Grækenland
      • Athens, Grækenland, 11527
      • Athens, Grækenland, 155 62
      • Patra, Grækenland, 26335
      • Thessaloniki, Grækenland, 56429
      • Thessaloniki, Grækenland, 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
  • Mexico
      • Guadalajara, Mexico, 44650
      • Guadalajara, Mexico, 44600
      • Guadalajara, Mexico, 45040
      • Mexicali, Mexico, 21100
      • Mexico Ctiy, Mexico, 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
  • Tyskland
      • Aachen, Tyskland, 52064
      • Bad Aibling, Tyskland, 83043
      • Bad Neuenahr-Ahrweiler, Tyskland, 53474
      • Bayreuth, Tyskland, 95445
      • Berlin, Tyskland, 13055
      • Dresden, Tyskland, 01109
      • Erfurt, Tyskland, 99096
      • Erlangen, Tyskland, 91056
      • Fulda, Tyskland, 36043
      • Hamburg, Tyskland, 22767
      • Hamburg, Tyskland, 22147
      • Heidelberg, Tyskland, 69121
      • Herne, Tyskland, 44652
      • Köln, Tyskland, 50937
      • Ludwigsfelde, Tyskland, 14974
      • München, Tyskland, 81541
      • München, Tyskland, 80639
      • Passau, Tyskland, 94032
      • Rostock, Tyskland, 18059
      • Stuttgart, Tyskland, 70178
      • Traunstein, Tyskland, 83278
      • Wuppertal, Tyskland, 42105
  • 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Adult patients with rheumatoid arthritis

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Kohorte

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2012

Primær færdiggørelse (Faktiske)

1. februar 2015

Studieafslutning (Faktiske)

1. februar 2015

Datoer for studieregistrering

Først indsendt

28. februar 2012

Først indsendt, der opfyldte QC-kriterier

28. februar 2012

Først opslået (Skøn)

5. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MA27950

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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