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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01169844
First received: July 14, 2010
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Psoriatic Arthritis
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 Psoriatic Arthritis

Resource links provided by NLM:


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 as measured by anti-AIN457 antibody in serum [ 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 as measured by AIN457 concentration in serum by a competitive ELISA assay. [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: November 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 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169844

Locations
Germany
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Hamburg, Germany, 22415
Novartis Investigative Site
Hamburg, Germany, 22081
Novartis Investigative Site
Herne, Germany, 44625
Novartis Investigative Site
Muenchen, Germany, 80336
Netherlands
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01169844     History of Changes
Other Study ID Numbers: CAIN457A2206E1
Study First Received: July 14, 2010
Last Updated: June 5, 2014
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:
Psoriatic arthritis
IgG1K monoclonal antibody
Interleukin -17A neutralizing

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014