Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis

Completed · Phase 2

Conditions studied: Ankylosing Spondylitis

In brief

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis 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 Intravenous infusion (IV) 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 ankylosing spondylitis a decision was taken to continue dosing for another 6 month period (Part 2).

Key facts

Study ID

NCT01109940

Run by

Novartis Pharmaceuticals

People needed

39

Starts

2010-04-01

Expected to finish

2012-12-01

Last updated by the study team

2021-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who took part and completed in the core CAIN457A2209 study
• Patients who discontinued the core study due to unsatisfactory therapeutic effect at their Visit 14 (Week 16) or later could enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, provided that at their discontinuation visit they fulfilled either one of the criteria below. Patients who did not enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, were required to come for an additional baseline visit (Visit 17) and were required to fulfill either one of the criteria below:
• No improvement (compared with the core study baseline) in two out of the following four domains: patient global assessment, pain, BASFI and the mean of the two morning stiffness questions from the BASDAI. OR
• Deterioration (compared with the core study baseline) in one of the four domains (deterioration defined as >=20% worsening and an absolute worsening of >=1 unit)

You may not qualify if…

• Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
• Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2209 study.
• Patients who discontinued from the core CAIN457A2209 study before Visit 14 (Week 16), and patients who completed the core study
• Pregnant or lactating women
• Presence of active infection
• Positive PPD or HIV test in patients where repeated testing was deemed appropriate due to their risk profile
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Paradise Valley, Arizona, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Jackson, Tennessee, United States
• Novartis Investigative Site — Knoxville, Tennessee, United States
• Novartis Investigative Site — Benbrook, Texas, United States
• Novartis Investigative Site — Spokane, Washington, United States
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Herne, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Amsterdamn, DE, Netherlands
• Novartis Investigative Site — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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