A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
NCT ID: NCT00642460
Last Updated: 2016-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
112 participants
INTERVENTIONAL
2008-05-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
tocilizumab [RoActemra/Actemra]
8mg/kg (patients\>=30kg) or 12mg/kg (patients \<30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule.
Non-steroidal anti-inflammatory drugs (NSAIDs)
as prescribed
methotrexate
as prescribed
corticosteroids
orally, as prescribed
2
Placebo
iv every 2 weeks for 12 weeks
Non-steroidal anti-inflammatory drugs (NSAIDs)
as prescribed
methotrexate
as prescribed
corticosteroids
orally, as prescribed
Interventions
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tocilizumab [RoActemra/Actemra]
8mg/kg (patients\>=30kg) or 12mg/kg (patients \<30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule.
Placebo
iv every 2 weeks for 12 weeks
Non-steroidal anti-inflammatory drugs (NSAIDs)
as prescribed
methotrexate
as prescribed
corticosteroids
orally, as prescribed
Eligibility Criteria
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Inclusion Criteria
* Systemic juvenile idiopathic arthritis with \>= 6 months persistent activity
* Presence of active disease (\>=5 active joints, or \>=2 active joints + fever + steroids)
* Inadequate clinical response to nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids due to toxicity or lack of efficacy
Exclusion Criteria
* Any other autoimmune, rheumatic disease or overlap syndrome other than systemic juvenile idiopathic arthritis
* Intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study
* Disease-modifying antirheumatic drugs (DMARDs), other than methotrexate
* Previous treatment with tocilizumab
2 Years
17 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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Little Rock, Arkansas, United States
Los Angeles, California, United States
Hartford, Connecticut, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Hackensack, New Jersey, United States
Livingston, New Jersey, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Houston, Texas, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
La Plata, , Argentina
Parkville, , Australia
Subiaco, , Australia
Westmead, , Australia
Ghent, , Belgium
Leuven, , Belgium
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Prague, , Czechia
Copenhagen, , Denmark
Berlin, , Germany
Bremen, , Germany
Sankt Augustin, , Germany
Athens, , Greece
Heraklion, , Greece
Ioannina, , Greece
Genova, , Italy
Milan, , Italy
Padua, , Italy
Roma, , Italy
México, , Mexico
Miexico City, , Mexico
Utrecht, , Netherlands
Oslo, , Norway
Krakow, , Poland
Lublin, , Poland
Piešťany, , Slovakia
Barcelona, , Spain
Esplugas de Llobregat, , Spain
Madrid, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Liverpool, , United Kingdom
London, , United Kingdom
Countries
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References
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Malattia C, Ruperto N, Pederzoli S, Palmisani E, Pistorio A, Wouters C, Dolezalova P, Flato B, Garay S, Giancane G, Wells C, Douglass W, Brunner HI, De Benedetti F, Ravelli A; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Tocilizumab may slow radiographic progression in patients with systemic or polyarticular-course juvenile idiopathic arthritis: post hoc radiographic analysis from two randomized controlled trials. Arthritis Res Ther. 2020 Sep 10;22(1):211. doi: 10.1186/s13075-020-02303-y.
Pardeo M, Wang J, Ruperto N, Alexeeva E, Chasnyk V, Schneider R, Horneff G, Huppertz HI, Minden K, Onel K, Zemel L, Martin A, Kone-Paut I, Siamopoulou-Mavridou A, Silva CA, Porter-Brown B, Bharucha KN, Brunner HI, De Benedetti F; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis. J Rheumatol. 2019 Sep;46(9):1117-1126. doi: 10.3899/jrheum.180795. Epub 2019 Mar 1.
De Benedetti F, Brunner H, Ruperto N, Schneider R, Xavier R, Allen R, Brown DE, Chaitow J, Pardeo M, Espada G, Gerloni V, Myones BL, Frane JW, Wang J, Lipman TH, Bharucha KN, Martini A, Lovell D; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group. Catch-up growth during tocilizumab therapy for systemic juvenile idiopathic arthritis: results from a phase III trial. Arthritis Rheumatol. 2015 Mar;67(3):840-8. doi: 10.1002/art.38984.
De Benedetti F, Brunner HI, Ruperto N, Kenwright A, Wright S, Calvo I, Cuttica R, Ravelli A, Schneider R, Woo P, Wouters C, Xavier R, Zemel L, Baildam E, Burgos-Vargas R, Dolezalova P, Garay SM, Merino R, Joos R, Grom A, Wulffraat N, Zuber Z, Zulian F, Lovell D, Martini A; PRINTO; PRCSG. Randomized trial of tocilizumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012 Dec 20;367(25):2385-95. doi: 10.1056/NEJMoa1112802.
Other Identifiers
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2007-000872-18
Identifier Type: -
Identifier Source: secondary_id
WA18221
Identifier Type: -
Identifier Source: org_study_id
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