Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.

Key facts

Study ID

NCT00669942

Run by

Novartis Pharmaceuticals

People needed

104

Starts

2005-12-01

Expected to finish

2008-11-01

Last updated by the study team

2015-03-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients with active rheumatoid arthritis in combination with a stable dose of methotrexate aged 18-75 years may participate in this trial.
• 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;

You may not qualify if…

• Current treatment with anti-TNF-α or anti IL-1 therapy (or other biological therapy).
• 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.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

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