Rheumatoid ArthritisNCT01557348
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
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 215 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 1,239 participants
- Where
- 215 sitesin 12 countries
- Study dates
- Jun 2009to Mar 2012
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid arthritis patients who are non-responders or intolerant to a single TNF-inhibitor
Who may be able to join
- 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
Who cannot join
- Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment
Trial locations and contacts
215 sites in 12 countries.
215 sites in 12 countries
France91 sites
Study site
Abbeville, 80142
Study site
Aix-les-Bains, 73106
Study site
Amiens, 80000
Study site
Amiens, 80094
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Argenteuil, 95107
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Bayonne, 64109
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Belfort, 90000
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Besançon, 25030
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Bonneville, 74136
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Bordeaux, 33076
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Bordeaux, 33100
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Boulogne-Billancourt, 92104
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Brest, 29609
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Bruges, 33523
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Bry-sur-Marne, 94366
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Caen, 14033
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Cahors, 46005
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Cambrai, 59407
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Cannes, 06401
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Carcassonne, 11890
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Carhaix-Plouguer, 29835
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Chambray-lès-Tours, 37171
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Clermont-Ferrand, 63000
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Clermont-Ferrand, 63003
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Colmar, 68024
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Corbeil-Essonnes, 91106
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Draguignan, 83300
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Échirolles, 38434
Study site
Évreux, 27023
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Issy-les-Moulineaux, 92130
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La Roche-sur-Yon, 85925
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La Source, 45100
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Laon, 02001
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Laval, 53015
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Le Coudray, 28360
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Le Kremlin-Bicêtre, 94275
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Le Mans, 72037
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Libourne, 33505
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Liévin, 62801
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Lille, 59037
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Limoges, 87000
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Limoges, 87042
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Lomme, 59160
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Lorient, 56322
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Lyon, 69002
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Lyon, 69275
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Lyon, 69448
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Maisons-Laffitte, 78600
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Mantes-la-Jolie, 78201
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Marseille, 13285
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Marseille, 13385
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Mennecy, 91540
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Metz, 57077
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Montauban, 82013
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Montauban, 82017
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Montivilliers, 76290
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Montpellier, 34295
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Mulhouse, 68070
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Nantes, 44093
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Nevers, 58033
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Nice, 06202
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Pachuca, 42070
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Paris, 75014
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Paris, 75018
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Paris, 75020
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Paris, 75475
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Paris, 75571
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Paris, 75651
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Paris, 75674
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Paris, 75679
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Paris, 75877
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Perpignan, 66046
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Pierre-Bénite, 69495
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Reims, 51092
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Reims, 51100
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Rennes, 35203
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Rodez, 12027
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Roubaix, 59056
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Saint-Aubin-lès-Elbeuf, 76410
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Saint-Brieuc, 22027
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Saint-Priest-en-Jarez, 42277
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Toulon, 83000
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Toulouse, 31000
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Toulouse, 31059
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Tours, 37000
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Valence, 26000
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Valenciennes, 59322
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Vandœuvre-lès-Nancy, 54511
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Vannes, 56017
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Villeneuve-sur-Lot, 47307
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Vincennes, 94300
United Kingdom38 sites
Study site
Abergavenny, NP7 7EG
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Aylesbury, HP21 8AL
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Blackburn, BB2 3HH
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Cambridge, CB2 2QQ
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Cannock, WS11 5XY
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Cardiff, CF14 4XW
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Cheltenham, GL53 7AN
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Chertsey, KT16 0PZ
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Cosham, PO6 3LY
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Derby, DE1 2QY
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Durham, DH15TW
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Exeter, EX2 5DW
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Glasgow, G12 0XH
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Harrogate, HG2 7SX
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Inverness, IV2 3UV
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Lancaster, LA1 4RP
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Leeds, LS7 4SA
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Lincoln, LN2 5QY
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Liverpool, L9 7AL
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London, SE1 9RT
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London, SE5 9PJ
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London, SW17 0QT
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Manchester, M13 9PT
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Metropolitan Borough of Wirral, CH49 5PE
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Poole, BH15 2JB
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Salford, M6 8HD
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Solihull, B91 2JL
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Southport, PR8 6PN
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St Helens, WA9 3DA
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Stockport, SK2 7JE
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Sunderland, SR4 7TP
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Sutton in Ashfield, NG17 4JL
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Torquay, TQ2 7AA
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Truro, TR1 3LJ
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Warrington, WA5 1QG
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Wolverhampton, DY1 2HQ
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Worthing, BN11 2DH
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Wrightington, WN6 9EP
Italy21 sites
Study site
Ancona, The Marches, 60020
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Bari, Apulia, 70124
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Coppito, Abruzzo, 67100
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Ferrara, Emilia-Romagna, 44100
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Florence, Tuscany, 50139
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Gazzi, Sicily, 98125
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Iesi, The Marches, 60035
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Milan, Lombardy, 20157
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Milan, Lombardy, 20162
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Modena, Emilia-Romagna, 41100
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Naples, Campania, 80131
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Padova, Veneto, 35128
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Palermo, Sicily, 90127
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Pisa, Tuscany, 56100
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Potenza, Basilicate, 85100
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Prato, Tuscany, 59100
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San Cesario di Lecce, Apulia, 73016
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Siena, Tuscany, 53100
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Telese Terme, Campania, 82037
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Udine, Friuli Venezia Giulia, 33100
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Verona, Veneto, 37134
Canada17 sites
Study site
Brampton, Ontario, L6T 3J1
Study site
Burlington, Ontario, L7R 1E2
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Hamilton, Ontario, L8N 1Y2
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Kitchener, Ontario, N2M 5N6
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London, Ontario, N6A 4V2
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Mississauga, Ontario, L5M 2V8
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H2L 1S6
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Montreal, Quebec, H3T 1Y6
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Rimouski, Quebec, G5L 8W1
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Saint John, New Brunswick, E4L 4L2
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Saskatoon, Saskatchewan, S7K 0H6
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St. Catharines, Ontario, L2N 7E4
Study site
Toronto, Ontario, M5G 1X5
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Toronto, Ontario, M9B 1B1
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Windsor, Ontario, N8X 5A6
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Winnipeg, Manitoba, R3A 1M3
Germany14 sites
Study site
Aachen, 52064
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Bremen, 28199
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Cologne, 50679
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Cuxhaven, 27476
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Erlangen, 91054
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Frankenberg, 09669
Study site
Frankfurt, 60596
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Gräfelfing, 82166
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Halle, 06128
Study site
Hanover, 30625
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Münster, 48149
Study site
Neuss, 41460
Study site
Rostock, 18059
Study site
Villingen-Schwenningen, 78054
Spain13 sites
Study site
Córdoba, Cordoba, 14004
Study site
El Palmar, Murcia, 30120
Study site
Granada, Granada, 18003
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Granada, Granada, 18014
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León, Leon, 24071
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Lorca, Murcia, 30800
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Lugo, Lugo, 27004
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Madrid, Madrid, 28034
Study site
Madrid, Madrid, 28222
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Madrid, Madrid, 28905
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Salamanca, Salamanca, 37007
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Seville, Sevilla, 41009
Study site
Torrevieja, 03186
Greece6 sites
Study site
Athens, 10676
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Athens, 11527
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Athens, 14527
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Athens, 155 62
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Athens, 16673
Study site
Larissa, 411 10
Mexico6 sites
Study site
Chihuahua City, 31238
Study site
Mexicali, 21100
Study site
Mexico City, 10700
Study site
Mexico City, 11850
Study site
Mexico City, 14141
Study site
Poza Rica Chacas, 93260
Portugal4 sites
Study site
Amadora, 3814-501
Study site
Guimarães, 4835-044
Study site
Lisbon, 1069-639
Study site
Porto, 4050-011
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at 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.
Measured: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6
Secondary outcomes (17)
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12
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.
Measured: 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
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.
Measured: Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in SJC at Months 6 and 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.
Measured: Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 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.
Measured: Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in ESR at Months 6 and 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.
Measured: Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 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.
Measured: Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 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.
Measured: Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 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.
Measured: Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 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.
Measured: Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 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.
Measured: 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
Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported.
Measured: Month 6 and Month 12
Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice
Measured: Up to 12 months
Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death
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.
Measured: Up to 12 Months
Number of Participants With Reasons for Discontinuation of the First TNFi Therapy
The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons. The other reasons included complete remission and participants' non-compliance.
Measured: Day 1 (Study entry visit)
Number of Participants With Previous TNFi Therapy
The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab). Number of participants with previous TNFi therapy history was reported.
Measured: Day 1 (Study entry visit)
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
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.
Measured: Day 1 (Study entry visit)
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startJun 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557348
- Sponsor's protocol ID
- MA22401
- Status last verified
- Nov 2016
- First submitted
- 13 Mar 2012
- Last updated
- 24 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov