Efficacy 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:
NCT00809614
First received: December 16, 2008
Last updated: January 29, 2015
Last verified: January 2015
  Purpose

This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis. The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses of AIN457 10 mg/kg administered three weeks apart.


Condition Intervention Phase
Psoriatic Arthritis
Biological: AIN457
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind Placebo-controlled Multi-center Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • ACR20 response at 6 weeks (ACR includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity) [ Time Frame: Interim analysis at 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 20%, 50% and 70% improvement compared to baseline as measured by ACR response criteria at screening, baseline and weeks 1, 2, 6, 8, 12, 16, 20 and 24 [ Time Frame: Up to 24 weeks post first infusion ] [ Designated as safety issue: No ]
  • PsARC response (based on measures of tender and swollen joint counts, and physician's and patient's global assessment of disease activity) at screening, baseline and weeks 1, 2, 6, 8, 12, 16, 20 and 24 [ Time Frame: Up to 24 weeks post first infusion ] [ Designated as safety issue: No ]
  • MASES (Mastricht Ankylosing Spondylitis Enthesis Score), SPARCC (SpA Research Consortium of Canada) and LDI (Leeds Dactylitis Instrument) at screening, baseline and weeks 1, 2, 6, 8, 12, 16 and 24 [ Time Frame: Up to 24 weeks post first infusion ] [ Designated as safety issue: No ]
  • PASI (Psoriasis Area and Severity Index) at screening, baseline and weeks 1, 2, 6, 8, 12, 16, 20 and 24 [ Time Frame: Up to 24 weeks post first infusion ] [ Designated as safety issue: No ]
  • Quality of Life Questionnaires: SF-36 at baseline and weeks 1, 2, 6, 12, 16 and 24 HAQ at screening and weeks 12 and 24 [ Time Frame: Up to 24 weeks post first infusion ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: March 2009
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 (2x 10mg/kg)
Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
Biological: AIN457
The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter.
Placebo Comparator: Placebo
Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
Biological: Placebo
Matching placebo to AIN457

  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

Exclusion Criteria:

  • Patients with arthritis or ankylosing spondyitis
  • Drug-induced psoriasis
  • Male or female patients who plan to conceive during the time course of the study, or for 6 months after the administration of the second dose.
  • Participation in any clinical trial within 4 weeks prior to initial dosing or longer.
  • Previous use of immunosuppressive agents eg cyclosporine, without the necessary wash-out period
  • History of severe allergy to food or drugs
  • Positive TB test. 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: NCT00809614

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00809614     History of Changes
Other Study ID Numbers: CAIN457A2206
Study First Received: December 16, 2008
Last Updated: January 29, 2015
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
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis

ClinicalTrials.gov processed this record on August 27, 2015