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

NCT01557348 | Completed Results

• 1 other identifier: MA22401
• Study Type: observational
• Target: 1,239
• Locations: 12 countries
• Sites: 215

Brief 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. Data will be collected from each patient from the time of change in biologic therapy for 12 months.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  Baseline, Month 6, and Month 12

• Least Squares Mean Change From Baseline in SJC at Months 6 and 12

  Baseline, Month 6, and Month 12

• Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12

  Baseline, Month 6, and Month 12

• Least Squares Mean Change From Baseline in ESR at Months 6 and 12

  Baseline, Month 6, and Month 12

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (215)

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Winnipeg, Manitoba, R3A 1M3, Canada

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Saint John, New Brunswick, E4L 4L2, Canada

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Brampton, Ontario, L6T 3J1, Canada

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Burlington, Ontario, L7R 1E2, Canada

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Hamilton, Ontario, L8N 1Y2, Canada

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Kitchener, Ontario, N2M 5N6, Canada

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London, Ontario, N6A 4V2, Canada

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Mississauga, Ontario, L5M 2V8, Canada

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St. Catharines, Ontario, L2N 7E4, Canada

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Toronto, Ontario, M5G 1X5, Canada

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Toronto, Ontario, M9B 1B1, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H2L 1S6, Canada

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Montreal, Quebec, H3T 1Y6, Canada

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Rimouski, Quebec, G5L 8W1, Canada

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Saskatoon, Saskatchewan, S7K 0H6, Canada

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Barranquilla, Colombia

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Bogotá, Colombia

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Cali, Colombia

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Abbeville, 80142, France

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Aix-les-Bains, 73106, France

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Amiens, 80000, France

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Amiens, 80094, France

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Argenteuil, 95107, France

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Bayonne, 64109, France

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Belfort, 90000, France

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Besançon, 25030, France

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Bonneville, 74136, France

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Bordeaux, 33076, France

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Bordeaux, 33100, France

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Boulogne-Billancourt, 92104, France

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Brest, 29609, France

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Bruges, 33523, France

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Bry-sur-Marne, 94366, France

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Caen, 14033, France

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Cahors, 46005, France

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Cambrai, 59407, France

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Cannes, 06401, France

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Carcassonne, 11890, France

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Carhaix-Plouguer, 29835, France

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Chambray-lès-Tours, 37171, France

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Clermont-Ferrand, 63000, France

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Clermont-Ferrand, 63003, France

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Colmar, 68024, France

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Corbeil-Essonnes, 91106, France

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Draguignan, 83300, France

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Échirolles, 38434, France

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Évreux, 27023, France

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Issy-les-Moulineaux, 92130, France

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La Roche-sur-Yon, 85925, France

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La Source, 45100, France

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Laon, 02001, France

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Laval, 53015, France

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Le Coudray, 28360, France

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Le Kremlin-Bicêtre, 94275, France

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Le Mans, 72037, France

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Libourne, 33505, France

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Liévin, 62801, France

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Lille, 59037, France

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Limoges, 87000, France

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Limoges, 87042, France

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Lomme, 59160, France

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Lorient, 56322, France

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Lyon, 69002, France

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Lyon, 69275, France

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Lyon, 69448, France

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Maisons-Laffitte, 78600, France

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Mantes-la-Jolie, 78201, France

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Marseille, 13285, France

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Marseille, 13385, France

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Mennecy, 91540, France

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Metz, 57077, France

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Montauban, 82013, France

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Montauban, 82017, France

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Montivilliers, 76290, France

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Montpellier, 34295, France

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Mulhouse, 68070, France

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Nantes, 44093, France

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Nevers, 58033, France

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Nice, 06202, France

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Pachuca, 42070, France

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Paris, 75014, France

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Paris, 75018, France

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Paris, 75020, France

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Paris, 75475, France

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Paris, 75571, France

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Paris, 75651, France

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Paris, 75674, France

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Paris, 75679, France

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Paris, 75877, France

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Perpignan, 66046, France

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Pierre-Bénite, 69495, France

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Reims, 51092, France

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Reims, 51100, France

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Rennes, 35203, France

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Rodez, 12027, France

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Roubaix, 59056, France

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Saint-Aubin-lès-Elbeuf, 76410, France

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Saint-Brieuc, 22027, France

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Saint-Priest-en-Jarez, 42277, France

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Toulon, 83000, France

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Toulouse, 31000, France

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Toulouse, 31059, France

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Tours, 37000, France

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Valence, 26000, France

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Valenciennes, 59322, France

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Vandœuvre-lès-Nancy, 54511, France

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Vannes, 56017, France

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Villeneuve-sur-Lot, 47307, France

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Vincennes, 94300, France

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Aachen, 52064, Germany

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Bremen, 28199, Germany

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Cologne, 50679, Germany

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Cuxhaven, 27476, Germany

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Erlangen, 91054, Germany

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Frankenberg, 09669, Germany

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Frankfurt, 60596, Germany

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Gräfelfing, 82166, Germany

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Halle, 06128, Germany

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Hanover, 30625, Germany

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Münster, 48149, Germany

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Neuss, 41460, Germany

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Rostock, 18059, Germany

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Villingen-Schwenningen, 78054, Germany

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Athens, 10676, Greece

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Athens, 11527, Greece

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Athens, 14527, Greece

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Athens, 155 62, Greece

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Athens, 16673, Greece

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Larissa, 411 10, Greece

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Coppito, Abruzzo, 67100, Italy

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Bari, Apulia, 70124, Italy

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San Cesario di Lecce, Apulia, 73016, Italy

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Potenza, Basilicate, 85100, Italy

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Napoli, Campania, 80131, Italy

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Telese Terme, Campania, 82037, Italy

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Ferrara, Emilia-Romagna, 44100, Italy

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Modena, Emilia-Romagna, 41100, Italy

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Udine, Friuli Venezia Giulia, 33100, Italy

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Milan, Lombardy, 20157, Italy

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Milan, Lombardy, 20162, Italy

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Gazzi, Sicily, 98125, Italy

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Palermo, Sicily, 90127, Italy

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Ancona, The Marches, 60020, Italy

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Iesi, The Marches, 60035, Italy

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Florence, Tuscany, 50139, Italy

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Pisa, Tuscany, 56100, Italy

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Prato, Tuscany, 59100, Italy

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Siena, Tuscany, 53100, Italy

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Padua, Veneto, 35128, Italy

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Verona, Veneto, 37134, Italy

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Chihuahua City, 31238, Mexico

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Mexicali, 21100, Mexico

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Mexico City, 10700, Mexico

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Mexico City, 11850, Mexico

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Mexico City, 14141, Mexico

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Poza Rica Chacas, 93260, Mexico

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Monaco, 98012, Monaco

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Ålesund, 6026, Norway

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Amadora, 3814-501, Portugal

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Guimarães, 4835-044, Portugal

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Lisbon, 1069-639, Portugal

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Porto, 4050-011, Portugal

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Córdoba, Cordoba, 14004, Spain

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Granada, Granada, 18003, Spain

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Granada, Granada, 18014, Spain

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León, Leon, 24071, Spain

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Lugo, Lugo, 27004, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28222, Spain

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Madrid, Madrid, 28905, Spain

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El Palmar, Murcia, 30120, Spain

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Lorca, Murcia, 30800, Spain

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Salamanca, Salamanca, 37007, Spain

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Seville, Sevilla, 41009, Spain

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Torrevieja, 03186, Spain

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Abergavenny, NP7 7EG, United Kingdom

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Aylesbury, HP21 8AL, United Kingdom

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Blackburn, BB2 3HH, United Kingdom

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Cambridge, CB2 2QQ, United Kingdom

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Cannock, WS11 5XY, United Kingdom

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Cardiff, CF14 4XW, United Kingdom

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Cheltenham, GL53 7AN, United Kingdom

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Chertsey, KT16 0PZ, United Kingdom

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Cosham, PO6 3LY, United Kingdom

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Derby, DE1 2QY, United Kingdom

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Durham, DH15TW, United Kingdom

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Exeter, EX2 5DW, United Kingdom

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Glasgow, G12 0XH, United Kingdom

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Harrogate, HG2 7SX, United Kingdom

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Inverness, IV2 3UV, United Kingdom

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Lancaster, LA1 4RP, United Kingdom

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Leeds, LS7 4SA, United Kingdom

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Lincoln, LN2 5QY, United Kingdom

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Liverpool, L9 7AL, United Kingdom

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London, SE1 9RT, United Kingdom

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London, SE5 9PJ, United Kingdom

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London, SW17 0QT, United Kingdom

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Manchester, M13 9PT, United Kingdom

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Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

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Poole, BH15 2JB, United Kingdom

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Salford, M6 8HD, United Kingdom

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Solihull, B91 2JL, United Kingdom

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Southport, PR8 6PN, United Kingdom

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St Helens, WA9 3DA, United Kingdom

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Stockport, SK2 7JE, United Kingdom

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Sunderland, SR4 7TP, United Kingdom

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Sutton in Ashfield, NG17 4JL, United Kingdom

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Torquay, TQ2 7AA, United Kingdom

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Truro, TR1 3LJ, United Kingdom

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Warrington, WA5 1QG, United Kingdom

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Wolverhampton, DY1 2HQ, United Kingdom

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Worthing, BN11 2DH, United Kingdom

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Wrightington, WN6 9EP, United Kingdom

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 19, 2012
• Study Start: June 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 24, 2017
• Results First Posted: January 24, 2017

Record last verified: 2016-11

Locations

ES (13); GR (6); PT (4); IT (21); FR (91); ME (6); GB (38); DE (14); NO (1); CO (3); CA (17); MO (1)