Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients
NCT ID: NCT00669942
Last Updated: 2015-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
104 participants
INTERVENTIONAL
2005-12-31
2008-11-30
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
BASIC_SCIENCE
DOUBLE
Study Groups
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Part 1 - AIN457A 0.3 mg/kg
AIN457A 0.3 mg/kg was administered intravenously as a single dose.
AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Part 1 - AIN457A 1.0 mg/kg
AIN457A 1.0 mg/kg was administered intravenously as a single dose.
AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Part 1 - AIN457A 3.0 mg/kg
AIN457A 3.0 mg/kg was administered intravenously as a single dose.
AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Part 1 - AIN457A 10 mg/kg
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Part 1 - Placebo
Placebo to AIN457A was administered intravenously as a single dose.
Placebo
Placebo to AIN457
Parts 2 and 3 - AIN457A 1.0 mg/kg
AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Parts 2 and 3 - AIN457A 3.0 mg/kg
AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Parts 2 and 3 - AIN457A 10 mg/kg
AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Parts 2 and 3 - Placebo
Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
Placebo
Placebo to AIN457
Part 1 - Healthy Volunteers - AIN457A 3 mg/kg
AIN457A 3.0 mg/kg was administered intravenously as a single dose.
AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Part 1 - Healthy Volunteers - AIN457A 10 mg/kg
AIN457A 10 mg/kg was administered intravenously as a single dose.
AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Part 1 - Healthy Volunteers - Placebo
Placebo to AIN457A was administered intravenously as a single dose.
Placebo
Placebo to AIN457
Interventions
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AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Placebo
Placebo to AIN457
Eligibility Criteria
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Inclusion Criteria
* Post menopausal or surgically sterile female patients are allowed. Women of child-bearing potential may participate if they are on a stable dose of methotrexate and if they are practicing effective contraception for at least 6 months prior to screening, willing to use 2 forms of contraception, including at least 1 barrier method during the study and for at least 2 months following the completion/discontinuation of the study.
* Patients must have a diagnosis of active rheumatoid arthritis of stages I, II or III (ACR 1987 revised classification for criteria for RA). Disease duration of at least 6 months prior to randomization is essential;
Exclusion Criteria
* Patients with congestive heart failure or poorly controlled diabetes mellitus (HbA1c value ≥10%).
* Presence of any major chronic inflammatory autoimmune diseases like psoriasis, psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease or SLE that can mimic rheumatoid arthritis diagnosis or that can interfere with efficacy evaluation in the study.
* History of renal trauma, glomerulonephritis or patient with one kidney.
* Pregnant or breastfeeding women will be excluded.
* A positive tuberculin skin test.
18 Years
75 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
Role: PRINCIPAL_INVESTIGATOR
Novartis investigator site
Locations
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Novartis Investigative Site
Anniston, Alabama, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Largo, Florida, United States
Novartis Investigative Site
Ocala, Florida, United States
Novartis Investigative Site
Palm Harbor, Florida, United States
Novartis Investigative Site
Port Orange, Florida, United States
Novartis Investigative Site
Madisonville, Kentucky, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Omaha, Nebraska, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Bend, Oregon, United States
Novartis Investigative Site
Duncansville, Pennsylvania, United States
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Merksem, , Belgium
Novartis Investigative Site
Bad Nauheim, , Germany
Novartis Investigative Site
Erlangen, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Nijmegen, , Netherlands
Novartis Investigative Site
Singapore, Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore, Singapore
Novartis Investigative Site
A Coruña, Galicia, Spain
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain
Novartis Investigative Site
Guadalajara, , Spain
Countries
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References
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Hueber W, Patel DD, Dryja T, Wright AM, Koroleva I, Bruin G, Antoni C, Draelos Z, Gold MH; Psoriasis Study Group; Durez P, Tak PP, Gomez-Reino JJ; Rheumatoid Arthritis Study Group; Foster CS, Kim RY, Samson CM, Falk NS, Chu DS, Callanan D, Nguyen QD; Uveitis Study Group; Rose K, Haider A, Di Padova F. Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Sci Transl Med. 2010 Oct 6;2(52):52ra72. doi: 10.1126/scitranslmed.3001107.
Other Identifiers
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CAIN457A2101
Identifier Type: -
Identifier Source: org_study_id
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