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Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01109940
First received: April 22, 2010
Last updated: June 5, 2014
Last verified: June 2014

April 22, 2010
June 5, 2014
April 2010
December 2012   (final data collection date for primary outcome measure)
Safety and tolerability (Vital signs, ECG, Hematology; Blood chemistry; Urinalysis, Adverse Events, Immunogenicity) [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01109940 on ClinicalTrials.gov Archive Site
  • Immunogenicity of AIN457 [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: Yes ]
  • Total IL-17 concentration in blood at steady-state [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics of AIN457 at steady state [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis
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

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 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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ankylosing Spondylitis
Biological: AIN457A
Experimental: AIN457
Intervention: Biological: AIN457A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Netherlands,   United Kingdom
 
NCT01109940
CAIN457A2209E1, 2009-011591-30
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP