An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy

NCT00883753 | Completed Phase 3 Results

• 2 other identifiers: MA224602008-006924-68
• Study Type: interventional
• Target: 934
• Locations: 14 countries
• Sites: 171

Brief Summary

This study was an extension to study MA21573 \[NCT00750880\], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was \> 500 individuals.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. The percentage of participants with AEs and SAEs that occurred in the Extension Study grouped according to the number of disease-modifying anti-rheumatic drugs (DMARD) a participant was taking at Core Baseline is presented.

  108 Weeks

Secondary Outcomes (34)

• Percentage of Participants With Adverse Events Leading to Withdraw

  108 Weeks

• Time to Withdrawal Due to an Adverse Event (AE)

  108 Weeks

• Percentage of Participants With Discontinuation of Treatment Due to Any Cause

  108 Weeks

• Time to Discontinuation of Tocilizumab Treatment for Any Cause

  108 Weeks

• Percentage of Participants With Marked Lipid Abnormalities

  108 Weeks

Study Arms (1)

tocilizumab

EXPERIMENTAL

Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.

Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8 mg/kg IV (maximum dose not exceeding 800 mg in a single infusion) every 4 weeks.

tocilizumab

Eligibility Criteria

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

You may qualify if:

• \- patients who completed the 24-week MA21573 core study, had at least a moderate response based on EULAR definition criteria and no adverse events (AEs), serious adverse events (SAEs) or conditions that led to unacceptable risk of continued treatment.

You may not qualify if:

• as for MA21573.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (171)

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Canberra, Australian Capital Territory, 2601, Australia

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Coffs Harbour, New South Wales, 2450, Australia

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Kogarah, New South Wales, 2217, Australia

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Cairns, Queensland, 4870, Australia

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Adelaide, South Australia, 5041, Australia

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Fitzroy, Victoria, 3065, Australia

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Geelong, Victoria, 3220, Australia

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Melbourne, Victoria, 3168, Australia

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Edmonton, Alberta, T5M 0H4, Canada

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Lethbridge, Alberta, T1J 0N9, Canada

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Kelowna, British Columbia, V1Y 3G8, Canada

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Nanaimo, British Columbia, V9S 4S1, Canada

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Vancouver, British Columbia, V5Z 1L7, Canada

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Vancouver, British Columbia, V5Z 3Y1, Canada

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Quispamsis, New Brunswick, E2E 4J8, Canada

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St. John's, Newfoundland and Labrador, A1C 5B8, Canada

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Hamilton, Ontario, L8N 1Y2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M4K 1N2, Canada

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Toronto, Ontario, M5G 1X5, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Laval, Quebec, H7G 2E6, Canada

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Montreal, Quebec, H2L 1S6, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Québec, Quebec, G1V 3M7, Canada

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Rimouski, Quebec, G5L 8W1, Canada

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Saint-Eustache, Quebec, J7P 4J2, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Saskatoon, Saskatchewan, S7K 0H6, Canada

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Bruntál, 792 01, Czechia

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Ostrava, 722 00, Czechia

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Prague, 128 50, Czechia

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Sokolov, 356 01, Czechia

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Uherské Hradiště, 686 01, Czechia

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Zlín, 760 01, Czechia

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Belfort, 90016, France

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Caen, 14033, France

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Cahors, 46005, France

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Corbeil-Essonnes, 91106, France

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Dijon, 21000, France

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La Rochelle, 17019, France

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Liévin, 62806, France

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Lomme, 59462, France

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Lyon, 69365, France

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Lyon, 69437, France

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Marseille, 13385, 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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Paris, 75674, France

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Poitiers, 86021, France

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Reims, 51092, France

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Roubaix, 59056, France

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Saint-Brieuc, 22027, France

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Strasbourg, 67098, France

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Toulouse, 31059, France

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Valence, 26000, France

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Valenciennes, 59322, France

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Heraklion, 711 10, Greece

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Budapest, 1023, Hungary

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Eger, 3300, Hungary

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Szeged, 6724, Hungary

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Veszprém, 8200, Hungary

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Arenzano, 16011, Italy

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Legnano, 20025, Italy

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Milan, 20122, Italy

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Milan, 20132, Italy

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Milan, 20162, Italy

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Modena, 41100, Italy

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Monserrato, 09042, Italy

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Novara, 28100, Italy

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Palermo, 90127, Italy

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Potenza, 85100, Italy

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Roma, 00144, Italy

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Roma, 00152, Italy

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Siena, 53100, Italy

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Varese, 21100, Italy

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's-Hertogenbosch, 5223 GZ, Netherlands

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Alkmaar, 1815 JD, Netherlands

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Amsterdam, 1056 AB, Netherlands

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Apeldoorn, 7300 DS, Netherlands

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Arnhem, 6815 AD, Netherlands

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Bergen op Zoom, 4624 VT, Netherlands

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Den Helder, 1782GZ, Netherlands

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Enschede, 7511 JX, Netherlands

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Flushing, 4382 EE, Netherlands

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Gouda, 2803 HH, Netherlands

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Heerlen, 6419 PC, Netherlands

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Hilversum, 1213 HX, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Nieuwegein, 3430 EM, Netherlands

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Nijmegen, 6522 JV, Netherlands

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Roosendaal, 4708 AE, Netherlands

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Rotterdam, 3015 CE, Netherlands

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Rotterdam, 3079 DZ, Netherlands

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Schiedam, 3116 BA, Netherlands

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Spijkenisse, 3201 GZ, Netherlands

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The Hague, 2545 CH, Netherlands

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The Hague, 2597 AX, Netherlands

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Krakow, 31-121, Poland

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Poznan, 61-545, Poland

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Wroclaw, 50-556, Poland

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Almada, 2801-951, Portugal

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Coimbra, 3000-075, Portugal

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Lisbon, 1349-019, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 4200-319, Portugal

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Bucharest, 011172, Romania

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Bucharest, 020475, Romania

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Cluj-Napoca, 400006, Romania

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Jeddah, 21423, Saudi Arabia

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Jeddah, 21461, Saudi Arabia

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Jeddah, 21499, Saudi Arabia

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Alicante, Alicante, 03010, Spain

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Elche, Alicante, 03203, Spain

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Elda, Alicante, 03600, Spain

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Almería, Almeria, 04009, Spain

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Barcelona, Barcelona, 08025, Spain

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Barcelona, Barcelona, 08035, Spain

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Barcelona, Barcelona, 08036, Spain

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Barcelona, Barcelona, 08907, Spain

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Sabadell, Barcelona, 08208, Spain

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Terrassa, Barcelona, 08221, Spain

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Cáceres, Caceres, 10310, Spain

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Córdoba, Cordoba, 14004, Spain

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Granada, Granada, 18014, Spain

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Huesca, Huesca, 22004, Spain

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A Coruña, La Coruña, 15006, Spain

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Las Palmas de Gran Canaria, Las Palmas, 35020, Spain

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Lugo, Lugo, 27004, Spain

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Madrid, Madrid, 28006, Spain

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Madrid, Madrid, 28905, Spain

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Málaga, Malaga, 29010, Spain

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Salamanca, Salamanca, 37007, Spain

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Seville, Sevilla, 41013, Spain

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San Cristóbal de La Laguna, Tenerife, 38320, Spain

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Valencia, Valencia, 46010, Spain

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Valencia, Valencia, 46017, Spain

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Barnsley, S75 2EP, United Kingdom

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Basingstoke, RG24 9NA, United Kingdom

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Bournemouth, BH23 2JX, United Kingdom

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Brighton, BN2 5BE, United Kingdom

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Burton-on-Trent, DE13 0RB, United Kingdom

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Bury Saint Edmonds, IP33 2QZ, United Kingdom

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Cambridge, CB2 2QQ, United Kingdom

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Cardiff, CF14 4XW, United Kingdom

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Chelmsford, CM1 7ET, United Kingdom

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Dudley, DY1 2HQ, United Kingdom

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Eastbourne, BN21 2UD, United Kingdom

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Gillingham, ME7 5NY, United Kingdom

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Harrogate, HG2 7SX, United Kingdom

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Ipswich, IP4 5PD, United Kingdom

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Liverpool, L9 7AL, United Kingdom

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Llantrisant, CF72 8XR, United Kingdom

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London, E11 1NR, United Kingdom

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Londonderry, BT47 6SB, United Kingdom

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Maidstone, ME16 9QQ, United Kingdom

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Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

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Middlesbrough, TS4 3BW, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Reading, RG1 5AN, United Kingdom

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Salford, M6 8HD, United Kingdom

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Sheffield, S10 2JF, United Kingdom

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Southport, PR8 6PN, United Kingdom

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Swindon, SN3 6BB, United Kingdom

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Torquay, TQ2 7AA, United Kingdom

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Westcliffe-on-sea, SS0 0RY, United Kingdom

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Worthing, BN11 2DH, United Kingdom

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

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: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

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: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 6, 2014
• Results First Posted: August 6, 2014

Record last verified: 2014-08

Locations

CZ (6); CA (23); NL (22); SA (3); GB (31); PL (3); ES (25); IT (14); PT (5); AU (8); FR (23); RO (3); GR (1); HU (4)