Clinical trial NCT01109940: Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis
IgG1K monoclonal antibody
Interleukin -17A neutralizing
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Reported Adverse Events (AE's)
timeFrame: From start of the study up to 64 weeks
Secondary outcomes:
measure: Number of Participants Reported Positive Antibodies for Secukinumab
timeFrame: Pre-dose, Week 0, 8, 24, 40 and Week 64
measure: Total Interleukin (IL)- 17A Concentration in Blood at Steady-State
timeFrame: Pre-dose and at the end of infusion (up to 64 weeks)
measure: Maximum (Peak) Observed in Serum at Steady-State (Cmax,ss)
timeFrame: At end of infusion (Week 64)
measure: Minimum (Trough) Observed in Serum at Steady State (Cmin,ss)
timeFrame: Pre-dose (Week 0)
Other outcomes:
Locations:
city: Paradise Valley
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Duncansville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Benbrook
country: United States
facility: Novartis Investigative Site
state: Texas
city: Spokane
country: United States
facility: Novartis Investigative Site
state: Washington
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Herne
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Amsterdamn
country: Netherlands
facility: Novartis Investigative Site
state: DE
city: Newcastle upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: