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).
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Novartis Investigative Site, Berlin, Germany
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
Primary outcomes
-
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
-
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).
-
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.
-
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.
-
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.
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