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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00809159
First received: December 16, 2008
Last updated: June 17, 2011
Last verified: June 2011
  Purpose

This study is designed as a proof of concept of AIN457 in patients with ankylosing spondylitis. The study will address the evaluation of the efficacy at 6 and up to 28 weeks after two doses of AIN457 administered three weeks apart In Part 1 patients will be administered either AIN457 10 mg/kg or placebo. In Part 2, patients will be administered either 10 mg/kg, 1.0 mg/kg or 0.1 mg/kg AIN457. Thirty patients will be enrolled in Part 1 and an additional 30 patients into Part 2 (i.e. no patients will be enrolled into both Parts 1 and 2).


Condition Intervention Phase
Ankylosing Spondylitis
Drug: AIN457
Drug: ARIN457
Phase 1
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 Moderate to Severe Ankylosing Spondylitis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Part 1: ASAS20 response at 6 weeks (ASAS includes measures of patient global assessment, inflammatory back pain, Bath Ankylosing Spondylitis Functional Index (BASFI) and morning stiffness by BASDAI). Part 2: Change in BASDAI response at 6 weeks [ Time Frame: Interim analysis at 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 20% and 40% improvement compared to baseline as measured by ASAS response at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
  • ASAS 5/6 response (based on ASAS plus Bath Ankylosing Spondylitis Metrology Index (BASMI) and C reactive protein (acute phase reactant) at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
  • Physician's global assessment of disease activity at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
  • Quality of Life Questionnaires (SF-36 and ASQoL) at baseline and weeks 4, 12 and 28: [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
  • 44-joint count at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]
  • Maastricht Ankylosing Spondylitis Enthesis Score (MASES) and Leeds enthesis index (LEI)at screening, baseline and weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 and 28 [ Time Frame: Up to 28 weeks post first infusion ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2009
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Part 1 Exp 1 Drug: AIN457
Placebo Comparator: Arm 2 Part 1 P Drug: AIN457
Experimental: Arm 3 Part 2 Exp 1 Drug: AIN457
Experimental: Arm 4 Part 2 Exp 2 Drug: ARIN457
Experimental: Arm 5 Part 2 Exp 3 Drug: AIN457

  Eligibility

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

Inclusion Criteria:

  • Patients with moderate to severe ankylosing spondylitis
  • Other protocol defined inclusion criteria may apply

Exclusion Criteria:

  • Male or female patients who plan to conceive during the time course of the study and for 6 months following the second dose.
  • Participation in any clinical trial within 4 weeks prior to initial dosing or longer.
  • Previous use of immunosuppressive agents such as cyclosporine without the necessary wash-out period
  • History of severe allergy to food or drugs
  • Positive tuberculin test
  • Total ankylosis of the spine (end stage disease)
  • Patients with psoriatic arthritis
  • 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: NCT00809159

Locations
United States, Arizona
Arizona Arthritis & Rheumatology Associates, PC, 10599 N. Tatum Blvd Suite F-150,
Paradise Valley, Arizona, United States, 85253
United States, California
Westlake Medical Research, "1250 La Venta Drive
Westlake Village, California, United States, 91361
United States, Florida
Millenium Research, 1545 Hand Avenue, Suite 2,
Ormond Beach, Florida, United States, 32174
United States, Illinois
Springfield Clinic, 1025 South 6th Street
Springfield, Illinois, United States, 62704
The Arthritis Center, 1200 Centre West Drive
Springfield, Illinois, United States, 62704
United States, Oklahoma
Lynn Health Science Institute, 3555 NW 58th Street, Suite 800
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Altoona Center for Clinical Research, 175 Meadowbrook Lane,
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Low Country Rheumatology, 2860 Tricom Street,
North Charleston, South Carolina, United States, 29406
United States, Tennessee
The Arthritis Clinic,371 North Parkway, Suite #400
Jackson, Tennessee, United States, 38305
Rheumatology Consultants, PLLC, "4707 Papermill Drive
Knoxville, Tennessee, United States, 37909
United States, Washington
Arthritis Northwest, PLLC, "105 W 8th Avenue
Spokane, Washington, United States, 99204
Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigator Site
Hamburg, Germany
Novartis Investigative Site
Herne, Germany
Novartis Investigator Site
Munich, Germany
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands
Novartis Investigative Site
Leiden, Netherlands
Novartis Investigative Site
Maastricht, Netherlands
United Kingdom
Novartis Investigative Site
Leeds, United Kingdom
Novartis Investigative Site
Middlesborough, United Kingdom
Novartis Investigative Site
Oxford, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00809159     History of Changes
Other Study ID Numbers: CAIN457A2209
Study First Received: December 16, 2008
Last Updated: June 17, 2011
Health Authority: 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)
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014