A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients
NCT ID: NCT01426789
Last Updated: 2015-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2011-08-31
2014-02-28
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
TRIPLE
Study Groups
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Secukinumab
10 mg/kg intravenous (I.V.)
Secukinumab
In part 1 (blinded period), participants randomized to secukinumab received 10 mg/kg I.V.. Participants, enrolled in part 2 (open label), received secukinumab 300 mg subcutaneous.
Placebo
Placebo I.V.
Placebo
Matching placebo to secukinumab I.V.
Interventions
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Placebo
Matching placebo to secukinumab I.V.
Secukinumab
In part 1 (blinded period), participants randomized to secukinumab received 10 mg/kg I.V.. Participants, enrolled in part 2 (open label), received secukinumab 300 mg subcutaneous.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be either DMARD naive or have failed at least one DMARD agent (e.g. MTX, leflunamide or sulfasalazine)
* Patients are allowed up to 3 DMARDs at study entry (e.g. MTX, sulfasalazine or hydroxychloroquine) as long as their dose was stable for 4 weeks prior to initiating study treatment
* Disease activity at screening defined by ≥6 out of 28 tender joints and ≥6 out of 28 swollen joints and hsCRP \>10mg/L
Exclusion Criteria
* Previous exposure to secukinumab or any other biologic, including TNF inhibitors.
* Use of high potency opioid analgesics
* Pregnant or nursing (lactating) women
* Use of any investigational drug other than RA therapy and/or devices at the time of randomization or within 30 days or 5 half-lives of randomization, whichever is longer.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Tuscon, Arizona, United States
Novartis Investigative Site
Anahiem, California, United States
Novartis Investigative Site
Clearwater, Florida, United States
Novartis Investigative Site
Coral Gables, Florida, United States
Novartis Investigative Site
Fleming Island, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Pinellas Park, Florida, United States
Novartis Investigative Site
Venice, Florida, United States
Novartis Investigative Site
Marietta, Georgia, United States
Novartis Investigative Site
South Bend, Indiana, United States
Novartis Investigative Site
Springfield, Missouri, United States
Novartis Investigative Site
Albuquerque, New Mexico, United States
Novartis Investigative Site
Statesville, North Carolina, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Kortrijk, , Belgium
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Frankfurt am Main, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Herne, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Magdeburg, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Smolensk, Russia, Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Nizhny Novgorod, , Russia
Novartis Investigative Site
Petrozavodsk, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Tver', , Russia
Novartis Investigative Site
Yaroslavl, , Russia
Novartis Investigative Site
Yaroslavl, , Russia
Novartis Investigative Site
Manchester, Manchester, United Kingdom
Novartis Investigative Site
Belfast, , United Kingdom
Countries
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References
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Burmester GR, Durez P, Shestakova G, Genovese MC, Schulze-Koops H, Li Y, Wang YA, Lewitzky S, Koroleva I, Berneis AA, Lee DM, Hueber W. Association of HLA-DRB1 alleles with clinical responses to the anti-interleukin-17A monoclonal antibody secukinumab in active rheumatoid arthritis. Rheumatology (Oxford). 2016 Jan;55(1):49-55. doi: 10.1093/rheumatology/kev258. Epub 2015 Aug 12.
Other Identifiers
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CAIN457F2208
Identifier Type: -
Identifier Source: org_study_id
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