A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage
NCT ID: NCT01661140
Last Updated: 2016-10-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
427 participants
INTERVENTIONAL
2012-09-30
2015-02-28
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
DOUBLE
Study Groups
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Methotrexate (MTX) Tapering Dosage
At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks. At Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response will be randomized to the MTX Tapering group or MTX Maintenance group. In this arm participants will receive a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. Participants will also continue to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants will receive tocilizumab monotherapy.
Tocilizumab
8 mg/kg intravenously every 4 weeks for 72 weeks
Methotrexate (tapering dose)
Tapering doses of methotrexate (MTX) were administered weekly from Week 24 to Week 56. Tapering doses depended on dose administered to the subject during the open label period. First tapering occurred at randomization (Week 24), second tapering at Week 32, third tapering at Week 40 and final tapering at Week 48.
Methotrexate (MTX) Maintenance Dosage
At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks. At Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response will be randomized to the MTX Tapering group or MTX Maintenance group. In this arm participants will continue to be administered a stable dose of MTX in a double-blind fashion between Week 24 and Week 56. Participants will also continue to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants will receive tocilizumab monotherapy.
Methotrexate (stable dose)
Methotrexate (MTX) was administered weekly according to the subject's pre-study MTX dose
Tocilizumab
8 mg/kg intravenously every 4 weeks for 72 weeks
Interventions
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Methotrexate (stable dose)
Methotrexate (MTX) was administered weekly according to the subject's pre-study MTX dose
Tocilizumab
8 mg/kg intravenously every 4 weeks for 72 weeks
Methotrexate (tapering dose)
Tapering doses of methotrexate (MTX) were administered weekly from Week 24 to Week 56. Tapering doses depended on dose administered to the subject during the open label period. First tapering occurred at randomization (Week 24), second tapering at Week 32, third tapering at Week 40 and final tapering at Week 48.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active severe rheumatoid arthritis (DAS28 \> 5.1) according to European League of Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria
* Inadequate response to a trial of 2 DMARDs, including methotrexate, a trial being defined as 6 months with 2 months at standard dose; no previous treatment with a biologic agent such as a tumor necrosis factor (TNF) inhibitor
* Oral corticosteroids must have been at a stable dose of \</= 10 mg/day prednisolone or equivalent for at least 25 out of 28 days prior to start of treatment (Day 1)
Exclusion Criteria
* Rheumatic autoimmune disease other than rheumatoid arthritis
* Functional class IV as defined by the ACR Classification of Functional Status in RA
* Prior history of or current inflammatory joint disease other than RA
* Previous treatment with tocilizumab
* Previous treatment with any biologic drug (e.g. TNF inhibitor) that is used in the treatment of RA
* Intraarticular or parenteral corticosteroids within 6 weeks prior to enrollment
* Inadequate liver, bone marrow or hepatic function
* Positive for hepatitis B, hepatitis C or HIV infection
* Pregnant or breastfeeding women
* Females of child-bearing potential who are not using reliable means of contraception
* History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
* Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
* History of, or currently active, primary or secondary immunodeficiency
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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Aberdeen, , United Kingdom
Abergavenny, , United Kingdom
Ashford, , United Kingdom
Aylesbury, , United Kingdom
Barnsley, , United Kingdom
Basingstoke, , United Kingdom
Bournemouth, , United Kingdom
Brighton, , United Kingdom
Bury Saint Edmonds, , United Kingdom
Cambridge, , United Kingdom
Cannock, , United Kingdom
Cardiff, , United Kingdom
Chelmsford, , United Kingdom
Chester, , United Kingdom
Coventry, , United Kingdom
Crewe, , United Kingdom
Darlington, , United Kingdom
Derby, , United Kingdom
Dudley, , United Kingdom
Dundee, , United Kingdom
Eastbourne, , United Kingdom
Exeter, , United Kingdom
Gillingham, , United Kingdom
Greenock, , United Kingdom
Guildford, , United Kingdom
Harrogate, , United Kingdom
Hull, , United Kingdom
Isle of Wight, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
Llantrisant, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Londonderry, , United Kingdom
Maidstone, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Middlesbrough, , United Kingdom
North Shields, , United Kingdom
Northampton, , United Kingdom
Nottingham, , United Kingdom
Oldham, , United Kingdom
Plymouth, , United Kingdom
Reading, , United Kingdom
Salford, , United Kingdom
Salisbury, , United Kingdom
Sheffield, , United Kingdom
Somerset, , United Kingdom
Southampton, , United Kingdom
Southport, , United Kingdom
Stevenage, , United Kingdom
Stoke-on-Trent, , United Kingdom
Sunderland, , United Kingdom
Sutton in Ashfield, , United Kingdom
Swindon, , United Kingdom
Torquay, , United Kingdom
Truro, , United Kingdom
Walsall, , United Kingdom
Warwick, , United Kingdom
Westcliffe-on-sea, , United Kingdom
Wolverhampton, , United Kingdom
Worthing, , United Kingdom
Wrightington, , United Kingdom
York, , United Kingdom
Countries
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Other Identifiers
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2011-005260-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML28096
Identifier Type: -
Identifier Source: org_study_id
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