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An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor

28 novembre 2016 aggiornato da: Hoffmann-La Roche

A Global Multi-centre Observational Study in RA Patients Who Are Non Responders or Intolerant to a Single TNF Inhibitor.

This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.

Panoramica dello studio

Stato

Completato

Condizioni

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1239

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
    • New Brunswick
      • Saint John, New Brunswick, Canada, E4L 4L2
    • Ontario
      • Brampton, Ontario, Canada, L6T 3J1
      • Burlington, Ontario, Canada, L7R 1E2
      • Hamilton, Ontario, Canada, L8N 1Y2
      • Kitchener, Ontario, Canada, N2M 5N6
      • London, Ontario, Canada, N6A 4V2
      • Mississauga, Ontario, Canada, L5M 2V8
      • St. Catharines, Ontario, Canada, L2N 7E4
      • Toronto, Ontario, Canada, M5G 1X5
      • Toronto, Ontario, Canada, M9B 1B1
      • Windsor, Ontario, Canada, N8X 5A6
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H2L 1S6
      • Montreal, Quebec, Canada, H3T 1Y6
      • Rimouski, Quebec, Canada, G5L 8W1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Cali, Colombia
  • Francia
      • Abbeville, Francia, 80142
      • Aix Les Bains, Francia, 73106
      • Amiens, Francia, 80000
      • Amiens, Francia, 80094
      • Argenteuil, Francia, 95107
      • Bayonne, Francia, 64109
      • Belfort, Francia, 90000
      • Besancon, Francia, 25030
      • Bonneville, Francia, 74136
      • Bordeaux, Francia, 33076
      • Bordeaux, Francia, 33100
      • Boulogne-billancourt, Francia, 92104
      • Brest, Francia, 29609
      • Bruges, Francia, 33523
      • Bry Sur Marne, Francia, 94366
      • Caen, Francia, 14033
      • Cahors, Francia, 46005
      • Cambrai, Francia, 59407
      • Cannes, Francia, 06401
      • Carcassonne, Francia, 11890
      • Carhaix Plouguer, Francia, 29835
      • Chambray Les Tours, Francia, 37171
      • Clermont-Ferrand, Francia, 63000
      • Clermont-ferrand, Francia, 63003
      • Colmar, Francia, 68024
      • Corbeil-essonnes, Francia, 91106
      • Draguignan, Francia, 83300
      • Echirolles, Francia, 38434
      • Evreux, Francia, 27023
      • Issy Les Moulineaux, Francia, 92130
      • La Roche Sur Yon, Francia, 85925
      • La Source, Francia, 45100
      • Laon, Francia, 02001
      • Laval, Francia, 53015
      • Le Coudray, Francia, 28360
      • Le Kremlin Bicetre, Francia, 94275
      • Le Mans, Francia, 72037
      • Libourne, Francia, 33505
      • Lievin, Francia, 62801
      • Lille, Francia, 59037
      • Limoges, Francia, 87042
      • Limoges, Francia, 87000
      • Lomme, Francia, 59160
      • Lorient, Francia, 56322
      • Lyon, Francia, 69002
      • Lyon, Francia, 69275
      • Lyon, Francia, 69448
      • Maisons Laffitte, Francia, 78600
      • Mantes La Jolie, Francia, 78201
      • Marseille, Francia, 13285
      • Marseille, Francia, 13385
      • Mennecy, Francia, 91540
      • Metz, Francia, 57077
      • Montauban, Francia, 82017
      • Montauban, Francia, 82013
      • Montivilliers, Francia, 76290
      • Montpellier, Francia, 34295
      • Mulhouse, Francia, 68070
      • Nantes, Francia, 44093
      • Nevers, Francia, 58033
      • Nice, Francia, 06202
      • Pachuca, Francia, 42070
      • Paris, Francia, 75018
      • Paris, Francia, 75014
      • Paris, Francia, 75651
      • Paris, Francia, 75475
      • Paris, Francia, 75674
      • Paris, Francia, 75571
      • Paris, Francia, 75679
      • Paris, Francia, 75877
      • Paris, Francia, 75020
      • Perpignan, Francia, 66046
      • Pierre Benite, Francia, 69495
      • Reims, Francia, 51092
      • Reims, Francia, 51100
      • Rennes, Francia, 35203
      • Rodez, Francia, 12027
      • Roubaix, Francia, 59056
      • St Aubin Les Elbeuf, Francia, 76410
      • St Brieuc, Francia, 22027
      • St Priest En Jarez, Francia, 42277
      • Toulon, Francia, 83000
      • Toulouse, Francia, 31059
      • Toulouse, Francia, 31000
      • Tours, Francia, 37000
      • Valence, Francia, 26000
      • Valenciennes, Francia, 59322
      • Vandoeuvre-les-nancy, Francia, 54511
      • Vannes, Francia, 56017
      • Villeneuve Sur Lot, Francia, 47307
      • Vincennes, Francia, 94300
  • Germania
      • Aachen, Germania, 52064
      • Bremen, Germania, 28199
      • Cuxhaven, Germania, 27476
      • Erlangen, Germania, 91054
      • Frankenberg, Germania, 09669
      • Frankfurt, Germania, 60596
      • Gräfelfing, Germania, 82166
      • Halle, Germania, 06128
      • Hannover, Germania, 30625
      • Köln, Germania, 50679
      • Münster, Germania, 48149
      • Neuss, Germania, 41460
      • Rostock, Germania, 18059
      • Villingen-Schwenningen, Germania, 78054
  • Grecia
      • Athens, Grecia, 11527
      • Athens, Grecia, 16673
      • Athens, Grecia, 14527
      • Athens, Grecia, 155 62
      • Athens, Grecia, 10676
      • Larissa, Grecia, 411 10
  • Italia
    • Abruzzo
      • Coppito, Abruzzo, Italia, 67100
    • Basilicata
      • Potenza, Basilicata, Italia, 85100
    • Campania
      • Napoli, Campania, Italia, 80131
      • Telese Terme, Campania, Italia, 82037
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italia, 44100
      • Modena, Emilia-Romagna, Italia, 41100
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italia, 33100
    • Lombardia
      • Milano, Lombardia, Italia, 20157
      • Milano, Lombardia, Italia, 20162
    • Marche
      • Ancona, Marche, Italia, 60020
      • Jesi, Marche, Italia, 60035
    • Puglia
      • Bari, Puglia, Italia, 70124
      • San Cesario Di Lecce, Puglia, Italia, 73016
    • Sicilia
      • Gazzi, Sicilia, Italia, 98125
      • Palermo, Sicilia, Italia, 90127
    • Toscana
      • Firenze, Toscana, Italia, 50139
      • Pisa, Toscana, Italia, 56100
      • Prato, Toscana, Italia, 59100
      • Siena, Toscana, Italia, 53100
    • Veneto
      • Padova, Veneto, Italia, 35128
      • Verona, Veneto, Italia, 37134
  • Messico
      • Chihuahua, Messico, 31238
      • Mexicali, Messico, 21100
      • Mexico City, Messico, 10700
      • Mexico City, Messico, 11850
      • Mexico City, Messico, 14141
      • Pozarica, Messico, 93260
  • Monaco
      • Monaco, Monaco, 98012
  • Norvegia
      • Ålesund, Norvegia, 6026
  • Portogallo
      • Amadora, Portogallo, 3814-501
      • Guimaraes, Portogallo, 4835-044
      • Lisboa, Portogallo, 1069-639
      • Porto, Portogallo, 4050-011
  • Regno Unito
      • Abergavenny, Regno Unito, NP7 7EG
      • Aylesbury, Regno Unito, HP21 8AL
      • Blackburn, Regno Unito, BB2 3HH
      • Cambridge, Regno Unito, CB2 2QQ
      • Cannock, Regno Unito, WS11 5XY
      • Cardiff, Regno Unito, CF14 4XW
      • Cheltenham, Regno Unito, GL53 7AN
      • Chertsey, Regno Unito, KT16 0PZ
      • Cosham, Regno Unito, PO6 3LY
      • Derby, Regno Unito, DE1 2QY
      • Durham, Regno Unito, DH15TW
      • Exeter, Regno Unito, EX2 5DW
      • Glasgow, Regno Unito, G12 0XH
      • Harrogate, Regno Unito, HG2 7SX
      • Inverness, Regno Unito, IV2 3UV
      • Lancaster, Regno Unito, LA1 4RP
      • Leeds, Regno Unito, LS7 4SA
      • Lincoln, Regno Unito, LN2 5QY
      • Liverpool, Regno Unito, L9 7AL
      • London, Regno Unito, SE1 9RT
      • London, Regno Unito, SW17 0QT
      • London, Regno Unito, SE5 9PJ
      • Manchester, Regno Unito, M13 9PT
      • Poole, Regno Unito, BH15 2JB
      • Salford, Regno Unito, M6 8HD
      • Solihull, Regno Unito, B91 2JL
      • Southport, Regno Unito, PR8 6PN
      • St Helens, Regno Unito, WA9 3DA
      • Stockport, Regno Unito, SK2 7JE
      • Sunderland, Regno Unito, SR4 7TP
      • Sutton in Ashfield, Regno Unito, NG17 4JL
      • Torquay, Regno Unito, TQ2 7AA
      • Truro, Regno Unito, TR1 3LJ
      • Warrington, Regno Unito, WA5 1QG
      • Wirral, Regno Unito, CH49 5PE
      • Wolverhampton, Regno Unito, DY1 2HQ
      • Worthing, Regno Unito, BN11 2DH
      • Wrightington, Regno Unito, WN6 9EP
  • Spagna
      • Cordoba, Spagna, 14004
      • Granada, Spagna, 18014
      • Granada, Spagna, 18003
      • Leon, Spagna, 24071
      • Lugo, Spagna, 27004
      • Madrid, Spagna, 28034
      • Madrid, Spagna, 28905
      • Madrid, Spagna, 28222
      • Salamanca, Spagna, 37007
      • Sevilla, Spagna, 41009
      • Torrevieja, Spagna, 03186
    • Murcia
      • El Palmar, Murcia, Spagna, 30120
      • Lorca, Murcia, Spagna, 30800

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Rheumatoid arthritis patients who are non-responders or intolerant to a single TNF-inhibitor

Descrizione

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy
  • Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics

Exclusion Criteria:

  • Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Rituximab
Eligible participants will receive rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
Alternative TNFi
Eligible participants will receive alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6
Lasso di tempo: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6
The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.
Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12
Lasso di tempo: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12
The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.
Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12
Least Squares Mean Change From Baseline in TJC at Months 6 and 12
Lasso di tempo: Baseline, Month 6, and Month 12
The TJC is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). A total of 28 joints were assessed for tenderness. Decrease in score indicated an improvement in disease activity.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in SJC at Months 6 and 12
Lasso di tempo: Baseline, Month 6, and Month 12
The SJC is the most specific clinical method to quantify abnormalities in participants with RA. A total of 28 joints were assessed for swelling. Decrease in the score indicated improvement in disease activity.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12
Lasso di tempo: Baseline, Month 6, and Month 12
C-reactive protein (CRP) is an inflammation marker. Normal range is from 0-10 milligram/Liter. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in disease activity.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in ESR at Months 6 and 12
Lasso di tempo: Baseline, Month 6, and Month 12
The ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells sediment in a period of one hour. Normal range is 0-30 mm/hr. A reduction in the level of ESR is considered as an improvement in disease activity.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12
Lasso di tempo: Baseline, Month 6, and Month 12
Physician global assessment of disease was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12
Lasso di tempo: Baseline, Month 6, and Month 12
Patient Global Assessment of Disease was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12
Lasso di tempo: Baseline, Month 6, and Month 12
Participants were asked to assess their pain intensity (severity of pain) on a 100-millimeter (mm) VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain". Higher scores indicate worsening of disease.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12
Lasso di tempo: Baseline, Month 6, and Month 12
Health Assessment Questionnaire-Disability Index (HAQ-DI) is participant reported assessment of ability to perform tasks in 8 categories of daily living activities as dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item was scored on a 4-point scale from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3, where 0 = least difficulty and 3 = extreme difficulty.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12
Lasso di tempo: Baseline, Month 6, and Month 12
Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Participants with available data at the time of assessment were included in the analysis.
Baseline, Month 6, and Month 12
Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy
Lasso di tempo: Month 6 and Month 12
Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported.
Month 6 and Month 12
Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice
Lasso di tempo: Up to 12 months
Up to 12 months
Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death
Lasso di tempo: Up to 12 Months
An Adverse event is defined as any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Up to 12 Months
Number of Participants With Reasons for Discontinuation of the First TNFi Therapy
Lasso di tempo: Day 1 (Study entry visit)
The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons. The other reasons included complete remission and participants' non-compliance.
Day 1 (Study entry visit)
Number of Participants With Previous TNFi Therapy
Lasso di tempo: Day 1 (Study entry visit)
The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab). Number of participants with previous TNFi therapy history was reported.
Day 1 (Study entry visit)
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Lasso di tempo: Day 1 (Study entry visit)
The previous disease-modifying anti-rheumatic drugs therapy included auranofin, aurothioglucose, aurotioprol, azathioprine, chloroquine, ciclosporin, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate, methotrexate sodium, minocycline, penicillamine, sodium aurothiomalate, sodium aurotiosulfate, sulfasalazine, and tiopronin. Number of participants with previous disease-modifying anti-rheumatic drugs therapy was reported.
Day 1 (Study entry visit)
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
Lasso di tempo: Baseline
The factors included participant characteristics and the reasons that led to the selection of second biologic therapy following an insufficient response or intolerance to a single previous TNFi. The participant characteristics included participant's option for treatment and option for follow-up. The other reasons included RA disease (rheumatoid factor [RF] and cyclic citrullinated peptide [CCP] status), primary failure, and new treatment characteristics (rapidity of action, route of administration, frequency of administration, low infectious risk, and no lymphoma risk). Participants were included in more than one of these factors.
Baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2009

Completamento primario (Effettivo)

1 marzo 2012

Completamento dello studio (Effettivo)

1 marzo 2012

Date di iscrizione allo studio

Primo inviato

13 marzo 2012

Primo inviato che soddisfa i criteri di controllo qualità

16 marzo 2012

Primo Inserito (Stima)

19 marzo 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

24 gennaio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 novembre 2016

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MA22401

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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