Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: AIN457A
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ankylosing spondylitis; IgG1K monoclonal antibody; Interleukin -17A neutralizing

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