An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.
2 other identifiers
interventional
1,681
24 countries
273
Brief Summary
This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Sep 2008
Typical duration for phase_3 rheumatoid-arthritis
273 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 10, 2008
CompletedFirst Posted
Study publicly available on registry
September 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
August 7, 2014
CompletedJuly 22, 2015
June 1, 2015
2.8 years
September 10, 2008
July 15, 2014
June 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events (AEs): Overall Summary
Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.
Weeks 4, 8, 12, 16, 20, and 24
Secondary Outcomes (19)
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event
Baseline,Weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Weeks 4, 8, 12, 16, 20, and 24
DAS28 Scores by Visit
Baseline, Weeks 4, 8, 12, 16, 20, and 24
- +14 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- male and non-pregnant or nursing female patients \>=18 years of age;
- body weight \<=150kg;
- moderate to severe active RA (DAS28 \>=3.2) of \>=6 months duration;
- on \>=1 non-biologic DMARDs at a stable dose for a period of \>= 8 weeks prior to start of treatment;
- inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
- if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.
You may not qualify if:
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
- rheumatic autoimmune disease other than RA;
- prior history of, or current inflammatory joint disease other than RA;
- functional class IV as defined by the ACR Classification of Functional Status in RA.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (282)
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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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Parramatta Park, New South Wales, 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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Graz, 8036, Austria
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Graz-Eggenberg, 8020, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Stockerau, 2000, Austria
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Vienna, 1100, Austria
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Vienna, 1130, Austria
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Vienna, 1160, Austria
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Aalst, 9300, Belgium
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Brussels, 1000, Belgium
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Brussels, 1020, Belgium
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Heusy, 4802, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Merksem, 2170, Belgium
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Montignies S/ Sambre, 6061, Belgium
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Westmalle, 2390, Belgium
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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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BruntĂ¡l, 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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UherskĂ© HradiÅ¡tÄ›, 686 01, Czechia
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ZlĂn, 760 01, Czechia
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Aarhus, 8000, Denmark
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Copenhagen, 2100, Denmark
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Copenhagen, 2400, Denmark
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Esbjerg, 6700, Denmark
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Hjørring, 9800, Denmark
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Silkeborg, 8600, Denmark
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Helsinki, 00290, Finland
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Jyväskylä, 40100, Finland
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Turku, 20521, Finland
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Argenteuil, 95107, France
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Aulnay-sous-Bois, 93602, France
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Belfort, 90016, France
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Bobigny, 93009, France
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Bourg-en-Bresse, 01012, France
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Caen, 14033, France
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Cahors, 46005, France
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Colmar, 68024, 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, 75475, France
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Paris, 75674, France
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Pau, 64046, 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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Berlin, 13125, Germany
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Bielefeld, 33611, Germany
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Freiburg im Breisgau, 79098, Germany
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Greifswald, 17489, Germany
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Hamburg, 22081, Germany
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Jena, 07747, Germany
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Kiel, 24116, Germany
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Rostock, 18059, Germany
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SaarbrĂ¼cken, 66111, Germany
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Wuppertal, 42105, Germany
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WĂ¼rzburg, 97080, Germany
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Athens, 115 27, Greece
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Heraklion, 711 10, Greece
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Ioannina, 455 00, Greece
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PĂ¡trai, 265 04, Greece
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Thessaloniki, 546 42, Greece
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Thessaloniki, 56429, Greece
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Thessaloniki, 57010, Greece
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Thessaloniki, Greece
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Budapest, 1023, Hungary
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Eger, 3300, Hungary
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Gyula, 5700, Hungary
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Szeged, 6724, Hungary
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Veszprém, 8200, Hungary
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Bangalore, 560003, India
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Chennai, 600 020, India
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Hyderabad, 500004, India
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Jaipur, 302 015, India
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Kolkata, 700 020, India
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Kolkata, 700 072, India
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Ludhiana, 141001, India
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Mumbai, 400007, India
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New Delhi, 110076, India
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Pune, 411001, India
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Co Leitrim, Ireland
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Cork, Ireland
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Dublin, 15, Ireland
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Dublin, 4, Ireland
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Dublin, 7, Ireland
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Dublin, 9, Ireland
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Galway, Ireland
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Limerick, 0, Ireland
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Waterford, Ireland
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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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Pescara, 65100, 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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Luxembourg, 2763, Luxembourg
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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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Gorinchem, 4204 AA, 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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Leidschendam, 2262 BA, 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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AlmerĂa, Almeria, 04009, Spain
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Avilés, Avila, 33400, 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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Vic, Barcelona, 08500, Spain
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CĂ¡ceres, Caceres, 10310, Spain
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Cadiz, Cadiz, 11009, Spain
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Jerez de la Frontera, Cadiz, 11407, Spain
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CĂ³rdoba, 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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LeĂ³n, Leon, 24071, Spain
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Ponferrada, Leon, 24411, 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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MĂ¡laga, Malaga, 29010, Spain
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Murcia, Murcia, 30120, Spain
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Ourense, Orense, 32005, Spain
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Salamanca, Salamanca, 37007, Spain
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Seville, Sevilla, 41013, Spain
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San CristĂ³bal de La Laguna, Tenerife, 38320, Spain
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Santa Cruz de Tenerife, Tenerife, 38010, Spain
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Valencia, Valencia, 46010, Spain
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Valencia, Valencia, 46017, Spain
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Zaragoza, Zaragoza, 50009, Spain
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Falun, 79182, Sweden
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Huddinge, SE-141 86, Sweden
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Karlstad, 65185, Sweden
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Linköping, 58185, Sweden
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Malmo, 205 02, Sweden
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Skövde, 54185, Sweden
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Stockholm, 18288, Sweden
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Uppsala, 75185, Sweden
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VästerĂ¥s, 72189, Sweden
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Aarau, 5000, Switzerland
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Basel, 4055, Switzerland
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Fribourg, 1708, Switzerland
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Geneva, 1211, Switzerland
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Lucerne, 6000, Switzerland
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Sankt Gallen, 9007, Switzerland
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Zurich, 8091, Switzerland
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Ankara, 06100, Turkey (TĂ¼rkiye)
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Istanbul, 34662, Turkey (TĂ¼rkiye)
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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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Dundee, DD12 9SY, 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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Huddersfield, HD3 3EA, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann- LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
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
September 10, 2008
First Posted
September 11, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 22, 2015
Results First Posted
August 7, 2014
Record last verified: 2015-06