Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients
Rheumatoid Arthritis
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Part 1 - AIN457A 0.3 mg/kg
Part 1 - AIN457A 1.0 mg/kg
Part 1 - AIN457A 3.0 mg/kg
Part 1 - AIN457A 10 mg/kg
Part 1 - Placebo
Parts 2 and 3 - AIN457A 1.0 mg/kg
Parts 2 and 3 - AIN457A 3.0 mg/kg
Parts 2 and 3 - AIN457A 10 mg/kg
Parts 2 and 3 - Placebo
Part 1 - Healthy Volunteers - AIN457A 3 mg/kg
Part 1 - Healthy Volunteers - AIN457A 10 mg/kg
Part 1 - Healthy Volunteers - Placebo
AIN457A 0.3 mg/kg was administered intravenously as a single dose.
AIN457A 1.0 mg/kg was administered intravenously as a single dose.
AIN457A 3.0 mg/kg was administered intravenously as a single dose.
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Placebo to AIN457A was administered intravenously as a single dose.
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.
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.
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.
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.
AIN457A 3.0 mg/kg was administered intravenously as a single dose.
AIN457A 10 mg/kg was administered intravenously as a single dose.
Placebo to AIN457A was administered intravenously as a single dose.