A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy
NCT ID: NCT01209689
Last Updated: 2013-01-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
113 participants
INTERVENTIONAL
2010-10-31
2011-12-31
Brief Summary
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This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tocilizumab 4 mg/kg
Patients received tocilizumab 4 mg/kg intravenously every 4 weeks for 24 weeks.
Tocilizumab
Tocilizumab 8 mg/kg
Patients received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks.
Tocilizumab
Placebo
Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
Placebo
Interventions
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Tocilizumab
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ankylosing spondylitis as defined by the modified New York criteria for ≥ 3 months prior to baseline.
* Active disease at screening and baseline (Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] ≥ 4.0, spinal pain visual analog scale \[VAS\] ≥ 40).
* Inadequate response or intolerant to 1 or more previous non-steroidal anti-inflammatory drugs (NSAIDs).
* Inadequate response to treatment with etanercept, infliximab, adalimumab, or golimumab because of inadequate efficacy.
* Tumor necrosis factor (TNF) antagonist therapy must have been discontinued at least 8 weeks prior to baseline (etanercept 4 weeks).
* Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine, and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks prior to baseline).
* Oral corticosteroids (≥ 10 mg/day prednisone or equivalent) and NSAIDs/cyclooxygenase-2 \[COX-2\] inhibitors must be at stable dose for at least 4 weeks prior to baseline.
Exclusion Criteria
* Total ankylosis of spine (as determined by investigator).
* Inflammatory rheumatic disease other than ankylosing spondylitis.
* Active, acute uveitis at baseline.
* Previous treatment with tocilizumab.
* Intra-articular or tendon injections or parenteral corticosteroids within 4 weeks prior to screening.
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
* Active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infection.
* History of or currently active primary or secondary immunodeficiency.
* Body weight \> 150 kg.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Huntington Beach, California, United States
Aventura, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Idaho Falls, Idaho, United States
Wichita, Kansas, United States
Hagerstown, Maryland, United States
Saint Claire Shores, Michigan, United States
Freehold, New Jersey, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Duncansville, Pennsylvania, United States
Austin, Texas, United States
Houston, Texas, United States
Heidelberg, , Australia
Hobart, , Australia
Sydney, , Australia
Woodville, , Australia
Brussels, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Liège, , Belgium
Yvoir, , Belgium
Cuiabá, , Brazil
Goiânia, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Calgary, Alberta, Canada
Hamilton, Ontario, Canada
Kitchener, Ontario, Canada
Mississauga, Ontario, Canada
St. Catharines, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Trois-Rivières, Quebec, Canada
St. John's, , Canada
Bruntál, , Czechia
Hlučín, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Uherské Hradiště, , Czechia
Zlín, , Czechia
Esbjerg, , Denmark
Hellerup, , Denmark
Vejle, , Denmark
Besançon, , France
Bordeaux, , France
Boulogne-Billancourt, , France
Créteil, , France
Grenoble, , France
Le Kremlin-Bicêtre, , France
Lyon, , France
Montpellier, , France
Orléans, , France
Paris, , France
Paris, , France
Rouen, , France
Strasbourg, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Berlin, , Germany
Cologne, , Germany
Erlangen, , Germany
Frankfurt, , Germany
Gommern, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Herne, , Germany
München, , Germany
Regensburg, , Germany
Rostock, , Germany
Tübingen, , Germany
Würzburg, , Germany
Bangalore, , India
Bangalore, , India
Jaipur, , India
New Delhi, , India
Secunderabad, , India
Ferrara, , Italy
Florence, , Italy
Monserrato, , Italy
Padua, , Italy
Pisa, , Italy
Prato, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Siena, , Italy
Kaunas, , Lithuania
Klaipėda, , Lithuania
Amsterdam, , Netherlands
Amsterdam, , Netherlands
Amsterdam, , Netherlands
Bydgoszcz, , Poland
Krakow, , Poland
Lublin, , Poland
Poznan, , Poland
Torun, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Košice, , Slovakia
Piešťany, , Slovakia
Cape Town, , South Africa
Cape Town, , South Africa
Durban, , South Africa
Pinelands, , South Africa
Pretoria, , South Africa
Stellenbosch, , South Africa
A Coruña, , Spain
Alcorcón, , Spain
Barcelona, , Spain
Córdoba, , Spain
Lugo, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Oviedo, , Spain
Oviedo, , Spain
Sabadell, , Spain
Basingstoke, , United Kingdom
Bath, , United Kingdom
Greenock, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Salford, , United Kingdom
Stoke-on-Trent, , United Kingdom
Wigan, , United Kingdom
Countries
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References
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Sieper J, Porter-Brown B, Thompson L, Harari O, Dougados M. Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Ann Rheum Dis. 2014 Jan;73(1):95-100. doi: 10.1136/annrheumdis-2013-203559. Epub 2013 Jun 13.
Other Identifiers
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2009-017488-40
Identifier Type: -
Identifier Source: secondary_id
WA22908
Identifier Type: -
Identifier Source: org_study_id
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