Safety and tolerability of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitis

Conditions: Ankylosing spondylitis
MedDRA version: 14.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2009-011591-30-NL

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

• A diagnosis of ankylosing spondylitis
• Patients who took part in the core CAIN457A2209 study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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 or discontinued the core study more than 2 weeks before the baseline visit.
• 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: • To assess the immunogenicity of AIN457<br>• To assess the total IL-17 concentration in blood at steady-state<br>• To assess the pharmacokinetics of AIN457 at steady state<br>;Main Objective: To assess the safety and tolerability of AIN457 in patients, who participated in the core CAIN457A2209 phase II proof-of-concept study;Primary end point(s): Safety and tolerability (Vital signs, ECG, Hematology; Blood chemistry; Urinalysis, Adverse Events, Immunogenicity) ;Timepoint(s) of evaluation of this end point: up to 64 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Immunogenicity of AIN457, total IL-17 concentration in blood at steady-state and pharmacokinetics of AIN457 at steady state ;Timepoint(s) of evaluation of this end point: up to 64 weeks