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

12 januari 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Studietype

Observationeel

Inschrijving (Werkelijk)

1225

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Adult patients with rheumatoid arthritis

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Cohort

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2012

Primaire voltooiing (Werkelijk)

1 februari 2015

Studie voltooiing (Werkelijk)

1 februari 2015

Studieregistratiedata

Eerst ingediend

28 februari 2012

Eerst ingediend dat voldeed aan de QC-criteria

28 februari 2012

Eerst geplaatst (Schatting)

5 maart 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

10 februari 2016

Laatste update ingediend die voldeed aan QC-criteria

12 januari 2016

Laatst geverifieerd

1 januari 2016

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MA27950

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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