This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in psoriatic arthritis a decision will be made as to whether or not to continue dosing for another 6 month period (Part 2).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Amsterdam, DE, Netherlands
Novartis Investigative Site
Meerssen, KR, Netherlands
Novartis Investigative Site
Glasgow, United Kingdom
Number of Participants With Adverse Events and Serious Adverse Events
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Time frame: Up to 64 weeks (End of the Study Treatment)
Total IL-17 Concentration in Blood at Steady-state
Total IL-17 concentration was not reported due to assay limitations.
Time frame: Up to 64 weeks
Mean Serum Concentration Measured at Steady State
This outcome measure is assessing AIN457 Mean Serum Concentration Measured at Steady State. A competitive ELISA method was used for bioanalytical analyses and the anticipated LLOQ is 80 nanograms/mL serum.
Time frame: Weeks 0, 8, 16, 20, 24, 28, 32, 36, 40 and at 4 and 12 weeks after the last administration at Week 52.
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Novartis Investigative Site
Leeds, United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom