Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate
NCT ID: NCT01359943
Last Updated: 2015-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
221 participants
INTERVENTIONAL
2011-10-31
2013-12-31
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
DOUBLE
Study Groups
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secukinumab 10 mg/kg i.v. loading
secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
secukinumab (AIN457)
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
placebo
Matching placebo to AIN457 i.v. and to AIN457 s.c..
secukinumab 150 mg s.c. loading
secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
secukinumab (AIN457)
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
placebo
Matching placebo to AIN457 i.v. and to AIN457 s.c..
placebo
placebo at Weeks 0, 1, 2, 3, 4, 8 \& 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
secukinumab (AIN457)
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
placebo
Matching placebo to AIN457 i.v. and to AIN457 s.c..
Interventions
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secukinumab (AIN457)
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
placebo
Matching placebo to AIN457 i.v. and to AIN457 s.c..
Eligibility Criteria
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Inclusion Criteria
* must have been taking MTX for at least 3 months before randomization and must currently be on a stable dose of MTX for at least 4 weeks before randomization.
* At Baseline: Disease activity criteria defined by \>6 tender joints out of 68 and \>6 swollen joints out of 66 and with at least 1 of the following at screening: Anti-CCP antibodies positive OR Rheumatoid Factor positive and with at least 1 of the following at screening: hsCRP ≥ 10 mg/L OR ESR ≥ 28
Exclusion Criteria
* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
* Previous exposure ever to an anti-TNF-a agent or any other immunomodulatory biologic agent (experimental or approved)
* Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
* Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronan) required for treatment of arthritis within 4 weeks before randomization
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
Novartis Pharmceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Vestavia Hills, Alabama, United States
Novartis Investigative Site
Peoria, Arizona, United States
Novartis Investigative Site
Upland, California, United States
Novartis Investigative Site
Bowling Green, Kentucky, United States
Novartis Investigative Site
Tupelo, Mississippi, United States
Novartis Investigative Site
Lincoln, Nebraska, United States
Novartis Investigative Site
Jackson, Tennessee, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Pleven, Bulgaria, Bulgaria
Novartis Investigative Site
Plovdiv, Bulgaria, Bulgaria
Novartis Investigative Site
Plovdiv, Bulgaria, Bulgaria
Novartis Investigative Site
Sevlievo, Bulgaria, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, Bulgaria
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada
Novartis Investigative Site
Sainte-Foy, Quebec, Canada
Novartis Investigative Site
Szeged, Hungary, Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Valeggio sul Mincio, (vr), Italy
Novartis Investigative Site
Arenzano, GE, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Siena, SI, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Bialystok, , Poland
Novartis Investigative Site
Poznan, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
San Juan, , Puerto Rico
Novartis Investigative Site
Bardejov, Slovak Republic, Slovakia
Novartis Investigative Site
Lučenec, Slovakia, Slovakia
Novartis Investigative Site
Partizánske, Slovakia, Slovakia
Novartis Investigative Site
Piešťany, Slovakia, Slovakia
Novartis Investigative Site
Sabinov, Slovakia, Slovakia
Novartis Investigative Site
Stará Ľubovňa, Slovakia, Slovakia
Novartis Investigative Site
Topoľčany, Slovakia, Slovakia
Novartis Investigative Site
Trnava, Slovensko, Slovakia
Countries
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References
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Tlustochowicz W, Rahman P, Seriolo B, Krammer G, Porter B, Widmer A, Richards HB. Efficacy and Safety of Subcutaneous and Intravenous Loading Dose Regimens of Secukinumab in Patients with Active Rheumatoid Arthritis: Results from a Randomized Phase II Study. J Rheumatol. 2016 Mar;43(3):495-503. doi: 10.3899/jrheum.150117. Epub 2016 Feb 1.
Other Identifiers
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2010-024516-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457F2206
Identifier Type: -
Identifier Source: org_study_id
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