Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01169844
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis 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 psoriatic arthritis a decision will be made as to whether or not to continue dosing for another 6 month period (Part 2).

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Biological: AIN457A Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (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 Psoriatic Arthritis
Study Start Date : June 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AIN457 Biological: AIN457A

Primary Outcome Measures :
  1. Safety and tolerability (Vital signs, ECG, Hematology; Blood chemistry; Urinalysis, Adverse Events, Immunogenicity) [ Time Frame: Up to 64 weeks ]

Secondary Outcome Measures :
  1. Immunogenicity of AIN457 as measured by anti-AIN457 antibody in serum [ Time Frame: Up to 64 weeks ]
  2. Total IL-17 concentration in blood at steady-state [ Time Frame: Up to 64 weeks ]
  3. Pharmacokinetics of AIN457 at steady state as measured by AIN457 concentration in serum by a competitive ELISA assay. [ Time Frame: Up to 64 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A diagnosis of psoriatic arthritis
  • Patients who took part in the core CAIN457A2206E1 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 CAIN457A2206 study.
  • Patients who discontinued from the core CAIN457A2206 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01169844

Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Hamburg, Germany, 22081
Novartis Investigative Site
Hamburg, Germany, 22415
Novartis Investigative Site
Herne, Germany, 44649
Novartis Investigative Site
Muenchen, Germany, 80336
Novartis Investigative Site
Amsterdamn, DE, Netherlands, 1100
Novartis Investigative Site
Meerssen, KR, Netherlands, 6231
United Kingdom
Novartis Investigative Site
Glasgow, United Kingdom, G12 8TA
Novartis Investigative Site
Leeds, United Kingdom, LS7 4SA
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom, NE2 4HH
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01169844     History of Changes
Other Study ID Numbers: CAIN457A2206E1
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Psoriatic arthritis
IgG1K monoclonal antibody
Interleukin -17A neutralizing

Additional relevant MeSH terms:
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs