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

12 janvier 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

La polyarthrite rhumatoïde

Type d'étude

Observationnel

Inscription (Réel)

1225

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Adult patients with rheumatoid arthritis

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Cohorte

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Choy EH, Bernasconi C, Aassi M, Molina JF, Epis OM. Treatment of Rheumatoid Arthritis With Anti-Tumor Necrosis Factor or Tocilizumab Therapy as First Biologic Agent in a Global Comparative Observational Study. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1484-1494. doi: 10.1002/acr.23303. Epub 2017 Sep 6.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2012

Achèvement primaire (Réel)

1 février 2015

Achèvement de l'étude (Réel)

1 février 2015

Dates d'inscription aux études

Première soumission

28 février 2012

Première soumission répondant aux critères de contrôle qualité