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

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:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

U.S. FDA Resources

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

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

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 May 19, 2013