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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. november 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1239

Kontakter og lokationer

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

Studiesteder

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

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

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

Beskrivelse

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

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
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

Hoffmann-La Roche

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. juni 2009

Primær færdiggørelse (Faktiske)

1. marts 2012

Studieafslutning (Faktiske)

1. marts 2012

Datoer for studieregistrering

Først indsendt

13. marts 2012

Først indsendt, der opfyldte QC-kriterier

16. marts 2012

Først opslået (Skøn)

19. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MA22401

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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