Skip to main content
OpenTrials
Completed

NCT Number: NCT01109940

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

AIN457A

Biological

Primary outcomes

  1. Number of Participants Reported Adverse Events (AE's)

    Time frame: From start of the study up to 64 weeks

    AEs are 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.

Secondary outcomes

  1. Number of Participants Reported Positive Antibodies for Secukinumab

    Time frame: Pre-dose, Week 0, 8, 24, 40 and Week 64

    Immunogenicity (anti-drug antibodies) was assessed using an MSD bridging assay and a 3-tiered approach (screening, confirmation, titration).

  2. Total Interleukin (IL)- 17A Concentration in Blood at Steady-State

    Time frame: Pre-dose and at the end of infusion (up to 64 weeks)

    Total serum IL17A was not measured due to assay limitations.

  3. Maximum (Peak) Observed in Serum at Steady-State (Cmax,ss)

    Time frame: At end of infusion (Week 64)

    Concentration of Secukinumab at the end of infusion (Cmax,ss) was reported.

  4. Minimum (Trough) Observed in Serum at Steady State (Cmin,ss)

    Time frame: Pre-dose (Week 0)

    The concentration of secukinumab at pre-dose (Cmin,ss) in serum was reported.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Moderate to Severe Ankylosing Spondylitis

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 23, 2010
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.