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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: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Ankylosing Spondylitis
 Biological: AIN457A
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability (Vital signs, ECG, Hematology; Blood chemistry; Urinalysis, Adverse Events, Immunogenicity) [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 Biological: AIN457A

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109940

Locations
United States, Arizona
Novartis Investigative Site
Paradise Valley, Arizona, United States, 85253
United States, Illinois
Novartis Investigative Site
Springfield, Illinois, United States, 62703
Novartis Investigative Site
Springfield, Illinois, United States, 62704
United States, Oklahoma
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Novartis Investigative Site
Duncansville, Pennsylvania, United States, 16635
United States, Tennessee
Novartis Investigative Site
Jackson, Tennessee, United States, 38305
Novartis Investigative Site
Knoxville, Tennessee, United States, 37909
United States, Texas
Novartis Investigative Site
Benbrook, Texas, United States, 76126
United States, Washington
Novartis Investigative Site
Spokane, Washington, United States, 99204
Germany
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Hamburg, Germany, 22081
Novartis Investigative Site
Herne, Germany, 44625
Novartis Investigative Site
Munchen, Germany, D-80639
Netherlands
Novartis Investigative Site
Amsterdamn, DE, Netherlands, 1100
United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom, NE2 4HH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01109940     History of Changes
Other Study ID Numbers: CAIN457A2209E1, 2009-011591-30
Study First Received: April 22, 2010
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Novartis:
Ankylosing spondylitis
IgG1K monoclonal antibody
Interleukin -17A neutralizing

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
 Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013