Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis
- Conditions
- Ankylosing Spondylitis
- Interventions
- Biological: AIN457A
- Registration Number
- NCT01109940
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AIN457 AIN457A -
- Primary Outcome Measures
Name Time Method Number of Participants Reported Adverse Events (AE's) 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 Outcome Measures
Name Time Method Number of Participants Reported Positive Antibodies for Secukinumab 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).
Total Interleukin (IL)- 17A Concentration in Blood at Steady-State Pre-dose and at the end of infusion (up to 64 weeks) Total serum IL17A was not measured due to assay limitations.
Maximum (Peak) Observed in Serum at Steady-State (Cmax,ss) At end of infusion (Week 64) Concentration of Secukinumab at the end of infusion (Cmax,ss) was reported.
Minimum (Trough) Observed in Serum at Steady State (Cmin,ss) Pre-dose (Week 0) The concentration of secukinumab at pre-dose (Cmin,ss) in serum was reported.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Newcastle upon Tyne, United Kingdom